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The study was prematurely discontinued due to slow enrollment and strategic considerations. This decision was not based on any safety or efficacy concerns.
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This observational study will enroll approximately 450 in patients. Patients treated with CAZ AVI for at least 1 dose at around 20 research centers in China will be enroll.
The recruitment will last for approximately 6 months or until recruitment target is met, and information about treatment will be collected from the patients' medical records. Patients will be followed from CAZ AVI initiation until death, withdraw of the study, 60 days after discharged from the hospitalization, whichever comes first. The endpoint events will be evaluated at: 7 days, 14 days, 21 days, 30 days, 60 days, and end of treatment (EOT) after CAZ AVI initiation, if patients are not discharged prior to the next upcoming timepoint; and 30 days, 60 days after discharge.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ceftazidime avibactam group | Receive ≥1 dose of ceftazidime avibactam in routine practice; Aged ≥ 18 years old at the time of the informed consent signature. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ceftazidime avibactam group | Drug | Non-Interventional Study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Success Rate at Day 7 | The clinical success rate was defined as the number of participants with clinical outcome as "success" in a specific visit / number of participants with clinical outcome assessed in a specific visit and was reported in terms of percentage of participants. Clinical outcome as success was defined as resolution of all signs and symptoms of infection such that no further antimicrobial therapy was necessary. 95% CI was based on Clopper-Pearson method. | Day 7 (from the data evaluated in approximately 21 months of the study) |
| Clinical Success Rate at Day 14 | The clinical success rate was defined as the number of participants with clinical outcome as "success" in a specific visit / number of participants with clinical outcome assessed in a specific visit and was reported in terms of percentage of participants. Clinical outcome as success was defined as resolution of all signs and symptoms of infection such that no further antimicrobial therapy was necessary. 95% CI was based on Clopper-Pearson method. | Day 14 (from the data evaluated in approximately 21 months of the study) |
| Clinical Success Rate at Day 21 | The clinical success rate was defined as the number of participants with clinical outcome as "success" in a specific visit / number of participants with clinical outcome assessed in a specific visit and was reported in terms of percentage of participants. Clinical outcome as success was defined as resolution of all signs and symptoms of infection such that no further antimicrobial therapy was necessary. 95% CI was based on Clopper-Pearson method. | Day 21 (from the data evaluated in approximately 21 months of the study) |
| Clinical Success Rate at Day 30 | The clinical success rate was defined as the number of participants with clinical outcome as "success" in a specific visit / number of participants with clinical outcome assessed in a specific visit and was reported in terms of percentage of participants. Clinical outcome as success was defined as resolution of all signs and symptoms of infection such that no further antimicrobial therapy was necessary. 95% CI was based on Clopper-Pearson method. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants According to Dose and Frequency of Ceftazidime-Avibactam: Full Analysis Set | Frequency of Ceftazidime-Avibactam was divided into: BID = Bis in die (twice a day), TID = Ter in die (thrice a day) and QD = Quaque die (once a day). A participant who had more than one record of treatment within the same dosage and frequency was counted only once. | From start of index treatment to end of index treatment (maximum 86 days of treatment exposure) (from the data evaluated in approximately 21 months of the study) |
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Inclusion criteria：
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Hospitalized patients treated with CAZ AVI for ≥1 dose in approximately 20 study sites.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital Fudan University | Shanghai | Shanghai Municipality | 200040 | China | ||
| Beijing Tsinghua Changgung Hospital |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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Data was abstracted from medical records and evaluated over approximately 21 months of this study.
Participants who received at least one dose of ceftazidime-avibactam during hospitalization were enrolled. Participants were recruited across 15 clinical research centers in China and were followed from first dose of ceftazidime-avibactam until death, withdrawal from study or 60 days post hospital discharge, whichever occurred first. Participants who initiated treatment with >=1 dose of ceftazidime-avibactam from 01 July 2022 to 31 December 2022 (index period of 6 months) were enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ceftazidime-Avibactam | Eligible participants who received at least one dose of ceftazidime-avibactam during hospitalization were enrolled in this study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Ceftazidime-Avibactam | Eligible participants who received at least one dose of ceftazidime-avibactam during hospitalization were enrolled in this study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Clinical Success Rate at Day 7 | The clinical success rate was defined as the number of participants with clinical outcome as "success" in a specific visit / number of participants with clinical outcome assessed in a specific visit and was reported in terms of percentage of participants. Clinical outcome as success was defined as resolution of all signs and symptoms of infection such that no further antimicrobial therapy was necessary. 95% CI was based on Clopper-Pearson method. | The clinically evaluable (CE) analysis set included all participants from the full analysis set (FAS) with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing clinical evaluation outcome. The FAS included all enrolled participants. The enrolled participants met the inclusion criteria, and did not meet the exclusion criteria. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Day 7 (from the data evaluated in approximately 21 months of the study) |
|
From index date up to 60 days after hospital discharge, in-hospital death, withdrawal from the study, or lost to follow-up, whichever occurred first (approximately 27 months including 6 months of index period); (from the data evaluated in approximately 21 months of the study)
The index date was defined as the date when participants initiated >=1 dose of ceftazidime-avibactam treatment during the index hospitalization. Index hospitalization was defined as when participants' first hospitalization met the eligible criteria. The FAS included all enrolled participants. The enrolled participants met the inclusion criteria, and did not meet the exclusion criteria.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ceftazidime-Avibactam | Eligible participants who received at least one dose of ceftazidime-avibactam during hospitalization were enrolled in this study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 12, 2022 | Jul 8, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 20, 2024 | Jul 8, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000077299 | Healthcare-Associated Pneumonia |
| D053717 | Pneumonia, Ventilator-Associated |
| ID | Term |
|---|---|
| D003428 | Cross Infection |
| D007239 | Infections |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
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| Day 30 (from the data evaluated in approximately 21 months of the study) |
| Clinical Success Rate at Day 60 | The clinical success rate was defined as the number of participants with clinical outcome as "success" in a specific visit / number of participants with clinical outcome assessed in a specific visit and was reported in terms of percentage of participants. Clinical outcome as success was defined as resolution of all signs and symptoms of infection such that no further antimicrobial therapy was necessary. 95% CI was based on Clopper-Pearson method. | Day 60 (from the data evaluated in approximately 21 months of the study) |
| Clinical Success Rate at End of Treatment (EOT) | The clinical success rate was defined as the number of participants with clinical outcome as "success" in a specific visit / number of participants with clinical outcome assessed in a specific visit and was reported in terms of percentage of participants. Clinical outcome as success was defined as resolution of all signs and symptoms of infection such that no further antimicrobial therapy was necessary. 95% CI was based on Clopper-Pearson method. | At EOT (maximum 86 days of treatment exposure) (from the data evaluated in approximately 21 months of the study) |
| Microbiological Success Rate Based on the Evaluation by Site Investigator at Day 7 | The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (gram positive/fungi) (colonization). 95% CI was based on Clopper-Pearson method. | Day 7 (from the data evaluated in approximately 21 months of the study) |
| Microbiological Success Rate Based on the Evaluation by Site Investigator at Day 14 | The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method. | Day 14 (from the data evaluated in approximately 21 months of the study) |
| Microbiological Success Rate Based on the Evaluation by Site Investigator at Day 21 | The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method. | Day 21 (from the data evaluated in approximately 21 months of the study) |
| Microbiological Success Rate Based on the Evaluation by Site Investigator at Day 30 | The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method. | Day 30 (from the data evaluated in approximately 21 months of the study) |
| Microbiological Success Rate Based on the Evaluation by Site Investigator at Day 60 | The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method. | Day 60 (from the data evaluated in approximately 21 months of the study) |
| Microbiological Success Rate Based on the Evaluation by Site Investigator at EOT | The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method. | At EOT (maximum 86 days of treatment exposure) (from the data evaluated in approximately 21 months of the study) |
| Microbiological Success Rate Based on the Evaluation by Central Laboratory at Day 7 | The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method. | Day 7 (from the data evaluated in approximately 21 months of the study) |
| Microbiological Success Rate Based on the Evaluation by Central Laboratory at Day 14 | The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method. | Day 14 (from the data evaluated in approximately 21 months of the study) |
| Microbiological Success Rate Based on the Evaluation by Central Laboratory at Day 21 | The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method. | Day 21 (from the data evaluated in approximately 21 months of the study) |
| Microbiological Success Rate Based on the Evaluation by Central Laboratory at Day 30 | The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method. | Day 30 (from the data evaluated in approximately 21 months of the study) |
| Microbiological Success Rate Based on the Evaluation by Central Laboratory at Day 60 | The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method. | Day 60 (from the data evaluated in approximately 21 months of the study) |
| Microbiological Success Rate Based on the Evaluation by Central Laboratory at EOT | The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method. | At EOT (maximum 86 days of treatment exposure) (from the data evaluated in approximately 21 months of the study) |
| Microbiological Success Rate by Pathogen Based on the Evaluation by Site Investigator at Day 7 | The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method. | Day 7 (from the data evaluated in approximately 21 months of the study) |
| Microbiological Success Rate by Pathogen Based on the Evaluation by Site Investigator at Day 14 | The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method. | Day 14 (from the data evaluated in approximately 21 months of the study) |
| Microbiological Success Rate by Pathogen Based on the Evaluation by Site Investigator at Day 21 | The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method. | Day 21 (from the data evaluated in approximately 21 months of the study) |
| Microbiological Success Rate by Pathogen Based on the Evaluation by Site Investigator at Day 30 | The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method. | Day 30 (from the data evaluated in approximately 21 months of the study) |
| Microbiological Success Rate by Pathogen Based on the Evaluation by Site Investigator at Day 60 | The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method. | Day 60 (from the data evaluated in approximately 21 months of the study) |
| Microbiological Success Rate by Pathogen Based on the Evaluation by Site Investigator at EOT | The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method. | At EOT (maximum 86 days of treatment exposure) (from the data evaluated in approximately 21 months of the study) |
| Microbiological Success Rate by Pathogen Based on the Evaluation by Central Laboratory at Day 7 | The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method. | Day 7 (from the data evaluated in approximately 21 months of the study) |
| Microbiological Success Rate by Pathogen Based on the Evaluation by Central Laboratory at Day 14 | The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method. | Day 14 (from the data evaluated in approximately 21 months of the study) |
| Microbiological Success Rate by Pathogen Based on the Evaluation by Central Laboratory at Day 21 | The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method. | Day 21 (from the data evaluated in approximately 21 months of the study) |
| Microbiological Success Rate by Pathogen Based on the Evaluation by Central Laboratory at Day 30 | The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method. | Day 30 (from the data evaluated in approximately 21 months of the study) |
| Microbiological Success Rate by Pathogen Based on the Evaluation by Central Laboratory at Day 60 | The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method. | Day 60 (from the data evaluated in approximately 21 months of the study) |
| Microbiological Success Rate by Pathogen Based on the Evaluation by Central Laboratory at EOT | The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method. | At EOT (maximum 86 days of treatment exposure) (from the data evaluated in approximately 21 months of the study) |
| Number of Participants According to Indication for Ceftazidime-Avibactam at Index Date | Index date was defined as the date when participants initiated >=1 dose of ceftazidime-avibactam treatment during the index hospitalization. Index hospitalization was defined as when participants' first hospitalization met the eligibility criteria. | At index date (from the data evaluated in approximately 21 months of the study) |
| Number of Participants According to Source of Infection | Index date was defined as the date when participants initiated >=1 dose of ceftazidime-avibactam treatment during the index hospitalization. Index hospitalization was defined as when participants' first hospitalization met the eligibility criteria. | At index date (from the data evaluated in approximately 21 months of the study) |
| Number of Isolated Strains | The index date was defined as the date when participants initiated >=1 dose of ceftazidime-avibactam treatment during the index hospitalization. Index hospitalization was defined as when participants' first hospitalization met the eligible criteria. | At baseline (from 7 days prior to index date until index date) (from the data evaluated in approximately 21 months of the study) |
| Number of Strains With Resistance to Ceftazidime-Avibactam and Other Antibiotic Drugs | The index date was defined as the date when participants initiated >=1 dose of ceftazidime-avibactam treatment during the index hospitalization. Index hospitalization was defined as when participant's first hospitalization met the eligible criteria. Number of strains with resistance to ceftazidime-avibactam and other antibiotic drugs is reported. One strain could be resistant to more than one antibiotic. | At baseline (from 7 days prior to index date until index date) (from the data evaluated in approximately 21 months of the study) |
| Number of Carbapenem-Resistant Strains | The index date was defined as the date when participants initiated >=1 dose of ceftazidime-avibactam treatment during the index hospitalization. Index hospitalization was defined as when participants' first hospitalization met the eligible criteria. | At baseline (from 7 days prior to index date until index date) (from the data evaluated in approximately 21 months of the study) |
| Number of Participants According to Dose and Frequency of Ceftazidime-Avibactam: Clinically Evaluable Analysis Set | Frequency of Ceftazidime-Avibactam was divided into: BID = Bis in die (twice a day), TID = Ter in die (thrice a day) and QD = Quaque die (once a day). A participant who had more than one record of treatment within the same dosage and frequency was counted only once. | From start of index treatment to end of index treatment (maximum 86 days of treatment exposure) (from the data evaluated in approximately 21 months of the study) |
| Duration of Exposure to Ceftazidime-Avibactam: Full Analysis Set | For a participant, each ceftazidime-avibactam administration period (days) was calculated as: ceftazidime-avibactam administration end date - ceftazidime-avibactam administration start date + 1. Duration of exposure (days) was obtained by summing up all ceftazidime-avibactam administration periods. | From start of index treatment to end of index treatment (maximum 86 days of treatment exposure) (from the data evaluated in approximately 21 months of the study) |
| Duration of Exposure to Ceftazidime-Avibactam: Clinically Evaluable Analysis Set | For a participant, each ceftazidime-avibactam administration period (days) was calculated as: ceftazidime-avibactam administration end date - ceftazidime-avibactam administration start date + 1. Duration of exposure (days) was obtained by summing up all ceftazidime-avibactam administration periods. | From start of index treatment to end of index treatment (maximum 86 days of treatment exposure) (from the data evaluated in approximately 21 months of the study) |
| Number of Participants Who Received Combination Therapy With Ceftazidime-Avibactam: Full Analysis Set | From start of index treatment to end of index treatment (maximum 86 days of treatment exposure) (from the data evaluated in approximately 21 months of the study) |
| Number of Participants Who Received Combination Therapy With Ceftazidime-Avibactam: Clinically Evaluable Analysis Set | From start of index treatment to end of index treatment (maximum 86 days of treatment exposure) (from the data evaluated in approximately 21 months of the study) |
| Hospital Length of Stay (LOS): Full Analysis Set | Hospital LOS was defined as date of hospital discharge minus date of hospital admission plus 1. The index date was defined as the date when participants initiated >=1 dose of ceftazidime-avibactam treatment during the index hospitalization. Index hospitalization was defined as when participants' first hospitalization met the eligible criteria. | From index date up to hospital discharge, in-hospital death, withdrawal from study, or lost to follow-up, whichever occurred first (approximately 27 months including 6 months of index period); (from data evaluated in approximately 21 months of the study) |
| Hospital Length of Stay (LOS): CE Analysis Set | Hospital LOS was defined as date of hospital discharge minus date of hospital admission plus 1. The index date was defined as the date when participants initiated >=1 dose of ceftazidime-avibactam treatment during the index hospitalization. Index hospitalization was defined as when participants' first hospitalization met the eligible criteria. | From index date up to hospital discharge, in-hospital death, withdrawal from study, or lost to follow-up, whichever occurred first (approximately 27 months including 6 months of index period); (from data evaluated in approximately 21 months of the study) |
| Intensive Care Unit (ICU) LOS: Full Analysis Set | Duration of ICU stay was defined as date of ICU discharge minus date of ICU admission plus 1. The index date was defined as the date when participants initiated >=1 dose of ceftazidime-avibactam treatment during the index hospitalization. Index hospitalization was defined as when participants' first hospitalization met the eligible criteria. | During index hospitalization, approximately 27 months including 6 months of index period; (from the data evaluated in approximately 21 months of the study) |
| ICU LOS: Clinically Evaluable Analysis Set | Duration of ICU stay was defined as date of ICU discharge minus date of ICU admission plus 1. The index date was defined as the date when participants initiated >=1 dose of ceftazidime-avibactam treatment during the index hospitalization. Index hospitalization was defined as when participants' first hospitalization met the eligible criteria. | During index hospitalization, approximately 27 months including 6 months of index period; (from the data evaluated in approximately 21 months of the study) |
| Number of Participants According to Most Frequent Diagnosis at Admission: Full Analysis Set | The number of participants reported according to the most frequent diagnosis at admission to the hospital were reported in this outcome measure. | At admission to the hospital (from the data evaluated in approximately 21 months of the study) |
| Number of Participants According to Most Frequent Diagnosis at Admission: Clinically Evaluable Analysis Set | The number of participants reported according to the most frequent diagnosis at admission to the hospital were reported in this outcome measure. | At admission to the hospital (from the data evaluated in approximately 21 months of the study) |
| Number of Participants According to Most Frequent Diagnosis at Discharge: Full Analysis Set | The number of participants reported according to the most frequent diagnosis at discharge from the hospital were reported in this outcome measure. | At discharge from the hospital (from the data evaluated in approximately 21 months of the study) |
| Number of Participants According to Most Frequent Diagnosis at Discharge: Clinically Evaluable Analysis Set | The number of participants reported according to the most frequent diagnosis at discharge from the hospital were reported in this outcome measure. | At discharge from the hospital (from the data evaluated in approximately 21 months of the study) |
| Number of Participants With at Least 1 Concomitant Procedures: Full Analysis Set | The number of participants with at least 1 concomitant procedure were reported in this outcome measure. The index date was defined as the date when participants initiated >=1 dose of ceftazidime-avibactam treatment during the index hospitalization. Index hospitalization was defined as when participants' first hospitalization met the eligible criteria. | From start of index treatment until death, withdraw of the study, 60 days following hospital discharge, whichever comes first (approximately 27 months including 6 months of index period); (from the data evaluated in approximately 21 months of the study) |
| Number of Participants With at Least 1 Concomitant Procedures: Clinically Evaluable Analysis Set | The number of participants with at least 1 concomitant procedure were reported in this outcome measure. The index date was defined as the date when participants initiated >=1 dose of ceftazidime-avibactam treatment during the index hospitalization. Index hospitalization was defined as when participants' first hospitalization met the eligible criteria. | From start of index treatment until death, withdraw of the study, 60 days following hospital discharge, whichever comes first (approximately 27 months including 6 months of index period); (from the data evaluated in approximately 21 months of the study) |
| Duration of Mechanical Ventilation: Full Analysis Set | For a participant, each mechanical ventilation period (days) was calculated as: mechanical ventilation end date - mechanical ventilation start date + 1. Length of mechanical ventilation (days) was obtained by summing up all mechanical ventilation periods. The index date was defined as the date when participants initiated >=1 dose of ceftazidime-avibactam treatment during the index hospitalization. Index hospitalization was defined as when participants' first hospitalization met the eligible criteria. | From start of index treatment until death, withdraw of the study, 60 days following hospital discharge, whichever comes first (approximately 27 months including 6 months of index period); (from the data evaluated in approximately 21 months of the study) |
| Duration of Mechanical Ventilation: Clinically Evaluable Analysis Set | For a participant, each mechanical ventilation period (days) was calculated as: mechanical ventilation end date - mechanical ventilation start date + 1. Length of mechanical ventilation (days) was obtained by summing up all mechanical ventilation periods. The index date was defined as the date when participants initiated >=1 dose of ceftazidime-avibactam treatment during the index hospitalization. Index hospitalization was defined as when participants' first hospitalization met the eligible criteria. | From start of index treatment until death, withdraw of the study, 60 days following hospital discharge, whichever comes first (approximately 27 months including 6 months of index period); (from the data evaluated in approximately 21 months of the study) |
| Percentage of Participants With Readmission Due to Recurrence of Infection Within 30 Days and 31-60 Days After Discharge: Full Analysis Set | 95% CI was based on Clopper-Pearson method. | Within 30 days and 31-60 days after discharge (from the data evaluated in approximately 21 months of the study) |
| Percentage of Participants With Readmission Due to Recurrence of Infection Within 30 Days and 31-60 Days After Discharge: CE Analysis Set | 95% CI was based on Clopper-Pearson method. | Within 30 days and 31-60 days after discharge (from the data evaluated in approximately 21 months of the study) |
| Percentage of Participants Who Died During Hospitalization: Full Analysis Set | In hospital-mortality was defined as deaths occurring after treatment initiation but before hospital discharge. The percentage of participants who died during index hospitalization were reported in this outcome measure. Index hospitalization was defined as when participants' first hospitalization met the eligible criteria. 95% CI was based on Clopper-Pearson method. | During index hospitalization (approximately 27 months including 6 months of index period); (from the data evaluated in approximately 21 months of the study) |
| Percentage of Participants Who Died During Hospitalization: Clinically Evaluable Analysis Set | In hospital-mortality was defined as deaths occurring after treatment initiation but before hospital discharge. The percentage of participants who died during index hospitalization were reported in this outcome measure. Index hospitalization was defined as when participants' first hospitalization met the eligible criteria. 95% CI was based on Clopper-Pearson method. | During index hospitalization (approximately 27 months including 6 months of index period); (from the data evaluated in approximately 21 months of the study) |
| Beijing |
| China |
| Xiangya Hospital Central South University | Changsha | China |
| The First Affiliated Hospital, Sun Yat-sen University | Guangzhou | China |
| Sir Run Run Shaw Hospital, Zhejiang University School of Medicine | Hangzhou | China |
| The Second Affiliated Hospital of Zhejiang University School of Medicine | Hangzhou | China |
| The First affiliated Hospital of Anhui Medical University | Hefei | China |
| The First Affiliated Hospital of Nanchang University | Nanchang | China |
| Zhongda Hospital Southeast University | Nanjing | China |
| The Affiliated People's Hospital of Ningbo University | Ningbo | China |
| Shanghai Tenth People's Hospital | Shanghai | China |
| The Second People's Hospital of Hebei Medical University | Shijiazhuang | China |
| The Third Hospital of Hebei Medical University | Shijiazhuang | China |
| The First Affiliated Hospital of Soochow University | Suzhou | China |
| Tianjin Medical University General Hospital | Tianjing | China |
| The First Affiliated Hospital of Xi'an Jiaotong University | Xi'an | China |
| Henan Provincial People's Hospital | Zhengzhou | China |
| Other |
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| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| OG000 | Ceftazidime-Avibactam | Eligible participants who received at least one dose of ceftazidime-avibactam during hospitalization were enrolled in this study. |
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| Primary | Clinical Success Rate at Day 14 | The clinical success rate was defined as the number of participants with clinical outcome as "success" in a specific visit / number of participants with clinical outcome assessed in a specific visit and was reported in terms of percentage of participants. Clinical outcome as success was defined as resolution of all signs and symptoms of infection such that no further antimicrobial therapy was necessary. 95% CI was based on Clopper-Pearson method. | The CE analysis set included all participants from the FAS with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing clinical evaluation outcome. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Day 14 (from the data evaluated in approximately 21 months of the study) |
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| Primary | Clinical Success Rate at Day 21 | The clinical success rate was defined as the number of participants with clinical outcome as "success" in a specific visit / number of participants with clinical outcome assessed in a specific visit and was reported in terms of percentage of participants. Clinical outcome as success was defined as resolution of all signs and symptoms of infection such that no further antimicrobial therapy was necessary. 95% CI was based on Clopper-Pearson method. | The CE analysis set included all participants from the FAS with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing clinical evaluation outcome. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Day 21 (from the data evaluated in approximately 21 months of the study) |
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| Primary | Clinical Success Rate at Day 30 | The clinical success rate was defined as the number of participants with clinical outcome as "success" in a specific visit / number of participants with clinical outcome assessed in a specific visit and was reported in terms of percentage of participants. Clinical outcome as success was defined as resolution of all signs and symptoms of infection such that no further antimicrobial therapy was necessary. 95% CI was based on Clopper-Pearson method. | The CE analysis set included all participants from the FAS with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing clinical evaluation outcome. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Day 30 (from the data evaluated in approximately 21 months of the study) |
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| Primary | Clinical Success Rate at Day 60 | The clinical success rate was defined as the number of participants with clinical outcome as "success" in a specific visit / number of participants with clinical outcome assessed in a specific visit and was reported in terms of percentage of participants. Clinical outcome as success was defined as resolution of all signs and symptoms of infection such that no further antimicrobial therapy was necessary. 95% CI was based on Clopper-Pearson method. | The CE analysis set included all participants from the FAS with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing clinical evaluation outcome. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Day 60 (from the data evaluated in approximately 21 months of the study) |
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| Primary | Clinical Success Rate at End of Treatment (EOT) | The clinical success rate was defined as the number of participants with clinical outcome as "success" in a specific visit / number of participants with clinical outcome assessed in a specific visit and was reported in terms of percentage of participants. Clinical outcome as success was defined as resolution of all signs and symptoms of infection such that no further antimicrobial therapy was necessary. 95% CI was based on Clopper-Pearson method. | The CE analysis set included all participants from the FAS with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing clinical evaluation outcome. | Posted | Number | 95% Confidence Interval | Percentage of Participants | At EOT (maximum 86 days of treatment exposure) (from the data evaluated in approximately 21 months of the study) |
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| Primary | Microbiological Success Rate Based on the Evaluation by Site Investigator at Day 7 | The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (gram positive/fungi) (colonization). 95% CI was based on Clopper-Pearson method. | The microbiologically evaluable (ME) analysis set included all participants from the FAS with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing microbiological evaluation outcome. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Day 7 (from the data evaluated in approximately 21 months of the study) |
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| Primary | Microbiological Success Rate Based on the Evaluation by Site Investigator at Day 14 | The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method. | The ME analysis set included all participants from the FAS with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing microbiological evaluation outcome. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Day 14 (from the data evaluated in approximately 21 months of the study) |
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| Primary | Microbiological Success Rate Based on the Evaluation by Site Investigator at Day 21 | The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method. | The ME analysis set included all participants from the FAS with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing microbiological evaluation outcome. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Day 21 (from the data evaluated in approximately 21 months of the study) |
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| Primary | Microbiological Success Rate Based on the Evaluation by Site Investigator at Day 30 | The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method. | The ME analysis set included all participants from the FAS with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing microbiological evaluation outcome. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Day 30 (from the data evaluated in approximately 21 months of the study) |
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| Primary | Microbiological Success Rate Based on the Evaluation by Site Investigator at Day 60 | The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method. | The ME analysis set included all participants from the FAS with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing microbiological evaluation outcome. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Day 60 (from the data evaluated in approximately 21 months of the study) |
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| Primary | Microbiological Success Rate Based on the Evaluation by Site Investigator at EOT | The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method. | The ME analysis set included all participants from the FAS with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing microbiological evaluation outcome. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of Participants | At EOT (maximum 86 days of treatment exposure) (from the data evaluated in approximately 21 months of the study) |
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| Primary | Microbiological Success Rate Based on the Evaluation by Central Laboratory at Day 7 | The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method. | The ME analysis set included all participants from the FAS with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing microbiological evaluation outcome. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Day 7 (from the data evaluated in approximately 21 months of the study) |
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| Primary | Microbiological Success Rate Based on the Evaluation by Central Laboratory at Day 14 | The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method. | The ME analysis set included all participants from the FAS with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing microbiological evaluation outcome. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Day 14 (from the data evaluated in approximately 21 months of the study) |
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| Primary | Microbiological Success Rate Based on the Evaluation by Central Laboratory at Day 21 | The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method. | The ME analysis set included all participants from the FAS with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing microbiological evaluation outcome. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Day 21 (from the data evaluated in approximately 21 months of the study) |
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| Primary | Microbiological Success Rate Based on the Evaluation by Central Laboratory at Day 30 | The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method. | The ME analysis set included all participants from the FAS with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing microbiological evaluation outcome. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Day 30 (from the data evaluated in approximately 21 months of the study) |
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| Primary | Microbiological Success Rate Based on the Evaluation by Central Laboratory at Day 60 | The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method. | The ME analysis set included all participants from the FAS with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing microbiological evaluation outcome. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Day 60 (from the data evaluated in approximately 21 months of the study) |
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| Primary | Microbiological Success Rate Based on the Evaluation by Central Laboratory at EOT | The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method. | The ME analysis set included all participants from the FAS with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing microbiological evaluation outcome. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of Participants | At EOT (maximum 86 days of treatment exposure) (from the data evaluated in approximately 21 months of the study) |
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| Primary | Microbiological Success Rate by Pathogen Based on the Evaluation by Site Investigator at Day 7 | The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method. | The ME analysis set included all participants from the FAS with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing microbiological evaluation outcome. All participants reported under, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure and contributed data to the table; however, may not have data evaluable for every row. ''Number Analyzed'' signifies participants evaluable for the specified rows. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Day 7 (from the data evaluated in approximately 21 months of the study) |
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| Primary | Microbiological Success Rate by Pathogen Based on the Evaluation by Site Investigator at Day 14 | The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method. | The ME analysis set included all participants from the FAS with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing microbiological evaluation outcome. All participants reported under, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure and contributed data to the table; however, may not have data evaluable for every row. ''Number Analyzed'' signifies participants evaluable for the specified rows. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Day 14 (from the data evaluated in approximately 21 months of the study) |
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| Primary | Microbiological Success Rate by Pathogen Based on the Evaluation by Site Investigator at Day 21 | The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method. | The ME analysis set included all participants from the FAS with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing microbiological evaluation outcome. All participants reported under, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure and contributed data to the table; however, may not have data evaluable for every row. ''Number Analyzed'' signifies participants evaluable for the specified rows. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Day 21 (from the data evaluated in approximately 21 months of the study) |
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| Primary | Microbiological Success Rate by Pathogen Based on the Evaluation by Site Investigator at Day 30 | The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method. | The ME analysis set included all participants from the FAS with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing microbiological evaluation outcome. All participants reported under, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure and contributed data to the table; however, may not have data evaluable for every row. ''Number Analyzed'' signifies participants evaluable for the specified rows. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Day 30 (from the data evaluated in approximately 21 months of the study) |
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| Primary | Microbiological Success Rate by Pathogen Based on the Evaluation by Site Investigator at Day 60 | The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method. | The ME analysis set included all participants from the FAS with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing microbiological evaluation outcome. All participants reported under, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure and contributed data to the table; however, may not have data evaluable for every row. ''Number Analyzed'' signifies participants evaluable for the specified rows. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Day 60 (from the data evaluated in approximately 21 months of the study) |
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| Primary | Microbiological Success Rate by Pathogen Based on the Evaluation by Site Investigator at EOT | The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method. | The ME analysis set included all participants from the FAS with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing microbiological evaluation outcome. All participants reported under, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure and contributed data to the table; however, may not have data evaluable for every row. ''Number Analyzed'' signifies participants evaluable for the specified rows. | Posted | Number | 95% Confidence Interval | Percentage of Participants | At EOT (maximum 86 days of treatment exposure) (from the data evaluated in approximately 21 months of the study) |
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| Primary | Microbiological Success Rate by Pathogen Based on the Evaluation by Central Laboratory at Day 7 | The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method. | The ME analysis set included all participants from the FAS with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing microbiological evaluation outcome. All participants reported under, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure and contributed data to the table; however, may not have data evaluable for every row. ''Number Analyzed'' signifies participants evaluable for the specified rows. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Day 7 (from the data evaluated in approximately 21 months of the study) |
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| Primary | Microbiological Success Rate by Pathogen Based on the Evaluation by Central Laboratory at Day 14 | The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method. | The ME analysis set included all participants from the FAS with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing microbiological evaluation outcome. All participants reported under, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure and contributed data to the table; however, may not have data evaluable for every row. ''Number Analyzed'' signifies participants evaluable for the specified rows. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Day 14 (from the data evaluated in approximately 21 months of the study) |
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| Primary | Microbiological Success Rate by Pathogen Based on the Evaluation by Central Laboratory at Day 21 | The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method. | The ME analysis set included all participants from the FAS with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing microbiological evaluation outcome. All participants reported under, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure and contributed data to the table; however, may not have data evaluable for every row. ''Number Analyzed'' signifies participants evaluable for the specified rows. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Day 21 (from the data evaluated in approximately 21 months of the study) |
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| Primary | Microbiological Success Rate by Pathogen Based on the Evaluation by Central Laboratory at Day 30 | The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method. | The ME analysis set included all participants from the FAS with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing microbiological evaluation outcome. All participants reported under, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure and contributed data to the table; however, may not have data evaluable for every row. ''Number Analyzed'' signifies participants evaluable for the specified rows. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Day 30 (from the data evaluated in approximately 21 months of the study) |
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| Primary | Microbiological Success Rate by Pathogen Based on the Evaluation by Central Laboratory at Day 60 | The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method. | The ME analysis set included all participants from the FAS with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing microbiological evaluation outcome. All participants reported under, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure and contributed data to the table; however, may not have data evaluable for every row. ''Number Analyzed'' signifies participants evaluable for the specified rows. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Day 60 (from the data evaluated in approximately 21 months of the study) |
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| Primary | Microbiological Success Rate by Pathogen Based on the Evaluation by Central Laboratory at EOT | The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method. | The ME analysis set included all participants from the FAS with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing microbiological evaluation outcome. All participants reported under, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure and contributed data to the table; however, may not have data evaluable for every row. ''Number Analyzed'' signifies participants evaluable for the specified rows. | Posted | Number | 95% Confidence Interval | Percentage of Participants | At EOT (maximum 86 days of treatment exposure) (from the data evaluated in approximately 21 months of the study) |
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| Primary | Number of Participants According to Indication for Ceftazidime-Avibactam at Index Date | Index date was defined as the date when participants initiated >=1 dose of ceftazidime-avibactam treatment during the index hospitalization. Index hospitalization was defined as when participants' first hospitalization met the eligibility criteria. | The FAS included all enrolled participants. The enrolled participants met the inclusion criteria, and did not meet the exclusion criteria. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | At index date (from the data evaluated in approximately 21 months of the study) |
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| Primary | Number of Participants According to Source of Infection | Index date was defined as the date when participants initiated >=1 dose of ceftazidime-avibactam treatment during the index hospitalization. Index hospitalization was defined as when participants' first hospitalization met the eligibility criteria. | The FAS included all enrolled participants. The enrolled participants met the inclusion criteria, and did not meet the exclusion criteria. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | At index date (from the data evaluated in approximately 21 months of the study) |
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| Primary | Number of Isolated Strains | The index date was defined as the date when participants initiated >=1 dose of ceftazidime-avibactam treatment during the index hospitalization. Index hospitalization was defined as when participants' first hospitalization met the eligible criteria. | The FAS included all enrolled participants. The enrolled participants met the inclusion criteria, and did not meet the exclusion criteria. Here, ''Overall Number of Units Analyzed'' signifies number of strains evaluable for this outcome measure. | Posted | Number | Strains | At baseline (from 7 days prior to index date until index date) (from the data evaluated in approximately 21 months of the study) | Strains | Strains |
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| Primary | Number of Strains With Resistance to Ceftazidime-Avibactam and Other Antibiotic Drugs | The index date was defined as the date when participants initiated >=1 dose of ceftazidime-avibactam treatment during the index hospitalization. Index hospitalization was defined as when participant's first hospitalization met the eligible criteria. Number of strains with resistance to ceftazidime-avibactam and other antibiotic drugs is reported. One strain could be resistant to more than one antibiotic. | The FAS included all enrolled participants. The enrolled participants met the inclusion criteria, and did not meet the exclusion criteria. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure. | Posted | Number | Strains | At baseline (from 7 days prior to index date until index date) (from the data evaluated in approximately 21 months of the study) | Strains | Strains |
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| Primary | Number of Carbapenem-Resistant Strains | The index date was defined as the date when participants initiated >=1 dose of ceftazidime-avibactam treatment during the index hospitalization. Index hospitalization was defined as when participants' first hospitalization met the eligible criteria. | The FAS included all enrolled participants. The enrolled participants met the inclusion criteria, and did not meet the exclusion criteria. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure. | Posted | Number | Strains | At baseline (from 7 days prior to index date until index date) (from the data evaluated in approximately 21 months of the study) | Strains | Strains |
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| Secondary | Number of Participants According to Dose and Frequency of Ceftazidime-Avibactam: Full Analysis Set | Frequency of Ceftazidime-Avibactam was divided into: BID = Bis in die (twice a day), TID = Ter in die (thrice a day) and QD = Quaque die (once a day). A participant who had more than one record of treatment within the same dosage and frequency was counted only once. | The FAS included all enrolled participants. The enrolled participants met the inclusion criteria, and did not meet the exclusion criteria. Here, ''Number Analyzed'' signifies participants evaluable for the specified dosage. All participants under "Number of Participants Analyzed" contributed data to the table but may not have evaluable data for every row. | Posted | Count of Participants | Participants | No | From start of index treatment to end of index treatment (maximum 86 days of treatment exposure) (from the data evaluated in approximately 21 months of the study) |
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| Secondary | Number of Participants According to Dose and Frequency of Ceftazidime-Avibactam: Clinically Evaluable Analysis Set | Frequency of Ceftazidime-Avibactam was divided into: BID = Bis in die (twice a day), TID = Ter in die (thrice a day) and QD = Quaque die (once a day). A participant who had more than one record of treatment within the same dosage and frequency was counted only once. | The FAS included all enrolled participants. The enrolled participants met the inclusion criteria, and did not meet the exclusion criteria. Here, ''Number Analyzed'' signifies participants evaluable for the specified dosage. All participants under "Number of Participants Analyzed" contributed data to the table but may not have evaluable data for every row. | Posted | Count of Participants | Participants | From start of index treatment to end of index treatment (maximum 86 days of treatment exposure) (from the data evaluated in approximately 21 months of the study) |
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| Secondary | Duration of Exposure to Ceftazidime-Avibactam: Full Analysis Set | For a participant, each ceftazidime-avibactam administration period (days) was calculated as: ceftazidime-avibactam administration end date - ceftazidime-avibactam administration start date + 1. Duration of exposure (days) was obtained by summing up all ceftazidime-avibactam administration periods. | The FAS included all enrolled participants. The enrolled participants met the inclusion criteria, and did not meet the exclusion criteria. | Posted | Median | Full Range | Days | From start of index treatment to end of index treatment (maximum 86 days of treatment exposure) (from the data evaluated in approximately 21 months of the study) |
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| Secondary | Duration of Exposure to Ceftazidime-Avibactam: Clinically Evaluable Analysis Set | For a participant, each ceftazidime-avibactam administration period (days) was calculated as: ceftazidime-avibactam administration end date - ceftazidime-avibactam administration start date + 1. Duration of exposure (days) was obtained by summing up all ceftazidime-avibactam administration periods. | The CE analysis set included all participants from the FAS with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing clinical evaluation outcome. | Posted | Median | Full Range | Days | From start of index treatment to end of index treatment (maximum 86 days of treatment exposure) (from the data evaluated in approximately 21 months of the study) |
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| Secondary | Number of Participants Who Received Combination Therapy With Ceftazidime-Avibactam: Full Analysis Set | The FAS included all enrolled participants. The enrolled participants met the inclusion criteria, and did not meet the exclusion criteria. | Posted | Count of Participants | Participants | From start of index treatment to end of index treatment (maximum 86 days of treatment exposure) (from the data evaluated in approximately 21 months of the study) |
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| Secondary | Number of Participants Who Received Combination Therapy With Ceftazidime-Avibactam: Clinically Evaluable Analysis Set | The CE analysis set included all participants from the FAS with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing clinical evaluation outcome. | Posted | Count of Participants | Participants | From start of index treatment to end of index treatment (maximum 86 days of treatment exposure) (from the data evaluated in approximately 21 months of the study) |
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| Secondary | Hospital Length of Stay (LOS): Full Analysis Set | Hospital LOS was defined as date of hospital discharge minus date of hospital admission plus 1. The index date was defined as the date when participants initiated >=1 dose of ceftazidime-avibactam treatment during the index hospitalization. Index hospitalization was defined as when participants' first hospitalization met the eligible criteria. | The FAS included all enrolled participants. The enrolled participants met the inclusion criteria, and did not meet the exclusion criteria. | Posted | Median | Full Range | Days | From index date up to hospital discharge, in-hospital death, withdrawal from study, or lost to follow-up, whichever occurred first (approximately 27 months including 6 months of index period); (from data evaluated in approximately 21 months of the study) |
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| Secondary | Hospital Length of Stay (LOS): CE Analysis Set | Hospital LOS was defined as date of hospital discharge minus date of hospital admission plus 1. The index date was defined as the date when participants initiated >=1 dose of ceftazidime-avibactam treatment during the index hospitalization. Index hospitalization was defined as when participants' first hospitalization met the eligible criteria. | The CE analysis set included all participants from the FAS with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing clinical evaluation outcome. | Posted | Median | Full Range | Days | From index date up to hospital discharge, in-hospital death, withdrawal from study, or lost to follow-up, whichever occurred first (approximately 27 months including 6 months of index period); (from data evaluated in approximately 21 months of the study) |
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| Secondary | Intensive Care Unit (ICU) LOS: Full Analysis Set | Duration of ICU stay was defined as date of ICU discharge minus date of ICU admission plus 1. The index date was defined as the date when participants initiated >=1 dose of ceftazidime-avibactam treatment during the index hospitalization. Index hospitalization was defined as when participants' first hospitalization met the eligible criteria. | The FAS included all enrolled participants. The enrolled participants met the inclusion criteria, and did not meet the exclusion criteria. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Posted | Median | Full Range | Days | During index hospitalization, approximately 27 months including 6 months of index period; (from the data evaluated in approximately 21 months of the study) |
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| Secondary | ICU LOS: Clinically Evaluable Analysis Set | Duration of ICU stay was defined as date of ICU discharge minus date of ICU admission plus 1. The index date was defined as the date when participants initiated >=1 dose of ceftazidime-avibactam treatment during the index hospitalization. Index hospitalization was defined as when participants' first hospitalization met the eligible criteria. | The CE analysis set included all participants from the FAS with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing clinical evaluation outcome. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Posted | Median | Full Range | Days | During index hospitalization, approximately 27 months including 6 months of index period; (from the data evaluated in approximately 21 months of the study) |
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| Secondary | Number of Participants According to Most Frequent Diagnosis at Admission: Full Analysis Set | The number of participants reported according to the most frequent diagnosis at admission to the hospital were reported in this outcome measure. | The FAS included all enrolled participants. The enrolled participants met the inclusion criteria, and did not meet the exclusion criteria. | Posted | Count of Participants | Participants | At admission to the hospital (from the data evaluated in approximately 21 months of the study) |
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| Secondary | Number of Participants According to Most Frequent Diagnosis at Admission: Clinically Evaluable Analysis Set | The number of participants reported according to the most frequent diagnosis at admission to the hospital were reported in this outcome measure. | The CE analysis set included all participants from the FAS with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing clinical evaluation outcome. | Posted | Count of Participants | Participants | At admission to the hospital (from the data evaluated in approximately 21 months of the study) |
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| Secondary | Number of Participants According to Most Frequent Diagnosis at Discharge: Full Analysis Set | The number of participants reported according to the most frequent diagnosis at discharge from the hospital were reported in this outcome measure. | The FAS included all enrolled participants. The enrolled participants met the inclusion criteria, and did not meet the exclusion criteria. | Posted | Count of Participants | Participants | At discharge from the hospital (from the data evaluated in approximately 21 months of the study) |
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| Secondary | Number of Participants According to Most Frequent Diagnosis at Discharge: Clinically Evaluable Analysis Set | The number of participants reported according to the most frequent diagnosis at discharge from the hospital were reported in this outcome measure. | The CE analysis set included all participants from the FAS with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing clinical evaluation outcome. | Posted | Count of Participants | Participants | At discharge from the hospital (from the data evaluated in approximately 21 months of the study) |
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| Secondary | Number of Participants With at Least 1 Concomitant Procedures: Full Analysis Set | The number of participants with at least 1 concomitant procedure were reported in this outcome measure. The index date was defined as the date when participants initiated >=1 dose of ceftazidime-avibactam treatment during the index hospitalization. Index hospitalization was defined as when participants' first hospitalization met the eligible criteria. | The FAS included all enrolled participants. The enrolled participants met the inclusion criteria, and did not meet the exclusion criteria. | Posted | Count of Participants | Participants | From start of index treatment until death, withdraw of the study, 60 days following hospital discharge, whichever comes first (approximately 27 months including 6 months of index period); (from the data evaluated in approximately 21 months of the study) |
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| Secondary | Number of Participants With at Least 1 Concomitant Procedures: Clinically Evaluable Analysis Set | The number of participants with at least 1 concomitant procedure were reported in this outcome measure. The index date was defined as the date when participants initiated >=1 dose of ceftazidime-avibactam treatment during the index hospitalization. Index hospitalization was defined as when participants' first hospitalization met the eligible criteria. | The CE analysis set included all participants from the FAS with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing clinical evaluation outcome. | Posted | Count of Participants | Participants | From start of index treatment until death, withdraw of the study, 60 days following hospital discharge, whichever comes first (approximately 27 months including 6 months of index period); (from the data evaluated in approximately 21 months of the study) |
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| Secondary | Duration of Mechanical Ventilation: Full Analysis Set | For a participant, each mechanical ventilation period (days) was calculated as: mechanical ventilation end date - mechanical ventilation start date + 1. Length of mechanical ventilation (days) was obtained by summing up all mechanical ventilation periods. The index date was defined as the date when participants initiated >=1 dose of ceftazidime-avibactam treatment during the index hospitalization. Index hospitalization was defined as when participants' first hospitalization met the eligible criteria. | The FAS included all enrolled participants. The enrolled participants met the inclusion criteria, and did not meet the exclusion criteria. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure. | Posted | Median | Full Range | Days | From start of index treatment until death, withdraw of the study, 60 days following hospital discharge, whichever comes first (approximately 27 months including 6 months of index period); (from the data evaluated in approximately 21 months of the study) |
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| Secondary | Duration of Mechanical Ventilation: Clinically Evaluable Analysis Set | For a participant, each mechanical ventilation period (days) was calculated as: mechanical ventilation end date - mechanical ventilation start date + 1. Length of mechanical ventilation (days) was obtained by summing up all mechanical ventilation periods. The index date was defined as the date when participants initiated >=1 dose of ceftazidime-avibactam treatment during the index hospitalization. Index hospitalization was defined as when participants' first hospitalization met the eligible criteria. | The CE analysis set included all participants from the FAS with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing clinical evaluation outcome. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure. | Posted | Median | Full Range | Days | From start of index treatment until death, withdraw of the study, 60 days following hospital discharge, whichever comes first (approximately 27 months including 6 months of index period); (from the data evaluated in approximately 21 months of the study) |
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| Secondary | Percentage of Participants With Readmission Due to Recurrence of Infection Within 30 Days and 31-60 Days After Discharge: Full Analysis Set | 95% CI was based on Clopper-Pearson method. | The FAS included all enrolled participants. The enrolled participants met the inclusion criteria, and did not meet the exclusion criteria. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Within 30 days and 31-60 days after discharge (from the data evaluated in approximately 21 months of the study) |
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| Secondary | Percentage of Participants With Readmission Due to Recurrence of Infection Within 30 Days and 31-60 Days After Discharge: CE Analysis Set | 95% CI was based on Clopper-Pearson method. | The CE analysis set included all participants from the FAS with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing clinical evaluation outcome. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Within 30 days and 31-60 days after discharge (from the data evaluated in approximately 21 months of the study) |
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| Secondary | Percentage of Participants Who Died During Hospitalization: Full Analysis Set | In hospital-mortality was defined as deaths occurring after treatment initiation but before hospital discharge. The percentage of participants who died during index hospitalization were reported in this outcome measure. Index hospitalization was defined as when participants' first hospitalization met the eligible criteria. 95% CI was based on Clopper-Pearson method. | The FAS included all enrolled participants. The enrolled participants met the inclusion criteria, and did not meet the exclusion criteria. | Posted | Number | 95% Confidence Interval | Percentage of Participants | During index hospitalization (approximately 27 months including 6 months of index period); (from the data evaluated in approximately 21 months of the study) |
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| Secondary | Percentage of Participants Who Died During Hospitalization: Clinically Evaluable Analysis Set | In hospital-mortality was defined as deaths occurring after treatment initiation but before hospital discharge. The percentage of participants who died during index hospitalization were reported in this outcome measure. Index hospitalization was defined as when participants' first hospitalization met the eligible criteria. 95% CI was based on Clopper-Pearson method. | The CE analysis set included all participants from the FAS with at least 72 hours use of ceftazidime-avibactam and at least 1 non-missing clinical evaluation outcome. | Posted | Number | 95% Confidence Interval | Percentage of Participants | During index hospitalization (approximately 27 months including 6 months of index period); (from the data evaluated in approximately 21 months of the study) |
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| 22 |
| 220 |
| 0 |
| 220 |
| 0 |
| 220 |
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publication until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Title | Measurements |
|---|---|
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| Enterobacter cloacae |
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| Escherichia coli |
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| Proteus mirabilis |
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| Klebsiella oxytoca |
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| Other |
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| Klebsiella pneumoniae: Imipenem |
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| Klebsiella pneumoniae: Tigecycline |
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| Klebsiella pneumoniae: Ceftazidime-Avibactam |
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| Klebsiella pneumoniae: Polymyxins |
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| Klebsiella pneumoniae: Polymyxin B |
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| Pseudomonas aeruginosa: Meropenem |
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| Pseudomonas aeruginosa: Imipenem |
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| Pseudomonas aeruginosa: Tigecycline |
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| Pseudomonas aeruginosa: Ceftazidime-Avibactam |
|
|
| Pseudomonas aeruginosa: Polymyxins |
|
|
| Pseudomonas aeruginosa: Polymyxin B |
|
|
| Title | Measurements |
|---|---|
|
| Serratia marcescens |
|
| Escherichia coli |
|
| Other |
|
|
| 2.5 grams: QD |
|
|
| 2.5 grams: Other |
|
|
| 1.25 grams: TID |
|
|
| 1.25 grams: BID |
|
|
| 1.25 grams: QD |
|
|
| 1.25 grams: Other |
|
|
| 0.94 grams: QD |
|
|
| 1 gram: BID |
|
|
| 2 grams: TID |
|
|
| 3 grams: BID |
|
|
|
| 2.5 grams: QD |
|
|
| 2.5 grams: Other |
|
|
| 1.25 grams: TID |
|
|
| 1.25 grams: BID |
|
|
| 1.25 grams: QD |
|
|
| 1.25 grams: Other |
|
|
| 0.94 grams: QD |
|
|
| 1 gram: BID |
|
|
| 2 grams: TID |
|
|
| 3 grams: BID |
|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|