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The main objective of this non-interventional (retrospective) study is to describe the general treatment patterns, effectiveness, and safety of ceftazidime-avibactam in real-world settings in India. Eligible patients would be adults who have been treated with ≥ 48 hours of ceftazidime-avibactam in routine practice from 01 June 2019 to 01 April 2020. Data of 500 patients will be collected through the abstraction of hospital medical records (electronic) if available or through the individual patient medical record in case electronic records are not available.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Eligible adults who have been treated with ≥ 48 hours of ceftazidime-avibactam in routine practice |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ceftazidime-avibactam | Drug | Non-Interventional Study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Clinical Symptom Improvement at Day 3 | The clinical symptom improvement was assessed as per the clinical judgement of the physician and reported as symptom improved and symptom worsened. | Day 3 after ceftazidime-avibactam initiation |
| Number of Participants With Treatment Success at Day 7 | The treatment success was defined as resolution of all signs and symptoms of the infection based on the clinician's judgment and the treatment protocol/algorithm followed at the respective centers. The treatment success in terms of clinical outcome was classified as clinical success (resolution of all signs and symptoms of the infection), clinical failure (persistence of signs and symptoms from baseline) and indeterminate (there is not enough information to conclude whether the antibiotic regimen containing ceftazidime-avibactam was a clinical failure or a success). | Day 7 after ceftazidime-avibactam initiation |
| Number of Participants With Treatment Success at Day 14 or End of Treatment | The treatment success was defined as resolution of all signs and symptoms of the infection based on the clinician's judgment and the treatment protocol/algorithm followed at the respective centers. The treatment success in terms of clinical outcome was classified as clinical success (resolution of all signs and symptoms of the infection), clinical failure (persistence of signs and symptoms from baseline) and indeterminate (there is not enough information to conclude whether the antibiotic regimen containing ceftazidime-avibactam was a clinical failure or a success). | Day 14 or End of Treatment after ceftazidime-avibactam initiation, whichever was earlier |
| Number of Participants With Microbiological Success at Day 7 | Microbiological success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication) and repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Classified According to Source of Infection at Baseline for Which Ceftazidime-Avibactam Was Used | Source of infection included hospital-acquired infection, healthcare-associated infection, and community-acquired infection. | Baseline (before initiation of initial antibiotic therapy) |
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Inclusion Criteria:
Exclusion Criteria:
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Hospitalized patients with documented gram negative infection and treated with Ceftazidime-avibactam for atleast 48 hours.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fortis Hospital | Bhandup West | 400078 | India | |||
| Apollo 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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Participants who were hospitalized with Gram negative infections and received ceftazidime-avibactam for at least 48 hours in routine clinical practice were included in this retrospective study. Data was collected from electronic health records or participant's medical records. Data was collected for the period from 01-Jun-2019 to 01-Apr-2020 (approximately 10 months).
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| ID | Title | Description |
|---|---|---|
| FG000 | Ceftazidime-Avibactam | Eligible participants who were hospitalized with Gram negative infections and received ceftazidime-avibactam for at least 48 hours in routine clinical practice were included. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Analysis population included all participants who received ceftazidime-avibactam for at least 48 hours.
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| ID | Title | Description |
|---|---|---|
| BG000 | Ceftazidime-Avibactam | Eligible participants who were hospitalized with Gram negative infections and received ceftazidime-avibactam for at least 48 hours in routine clinical practice were included. |
| 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 | Number of Participants With Clinical Symptom Improvement at Day 3 | The clinical symptom improvement was assessed as per the clinical judgement of the physician and reported as symptom improved and symptom worsened. | Analysis population included all participants who received ceftazidime-avibactam for at least 48 hours. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | Day 3 after ceftazidime-avibactam initiation |
|
Up to 30 days post treatment completion with ceftazidime-avibactam, death or discharge; whichever occurred first (up to Day 49)
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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 were hospitalized with Gram negative infections and received ceftazidime-avibactam for at least 48 hours in routine clinical practice were included. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer Clinical Trials.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 | Oct 21, 2020 | Mar 9, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 10, 2021 | Mar 9, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000595613 | avibactam, ceftazidime drug combination |
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| Day 7 after ceftazidime-avibactam initiation |
| Number of Participants With Microbiological Success at Day 14 or End of Treatment | Microbiological success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication) and repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication). | Day 14 or End of Treatment after ceftazidime-avibactam initiation, whichever was earlier |
| Number of Participants With Serious Adverse Events and Non-Serious Adverse Events With Explicit Attribution to Ceftazidime-Avibactam | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. All AEs that did not meet the criteria for "serious" were considered as non-serious. Adverse events with explicit attribution to any Pfizer drug that appeared in the reviewed information (defined per the participant population and study period specified in the protocol) were reported. Explicit attribution was not inferred by temporal relationship between drug administration and an AE, but was based on a causality assessed by a healthcare provider linking drug administration and AE. | Up to 30 days post treatment completion with ceftazidime-avibactam, death or discharge; whichever was first (Up to maximum of 49 days) |
| Number of Participants According to Indication at Baseline for Which Ceftazidime-Avibactam Was Used |
The indications for use of ceftazidime-avibactam at baseline including urinary tract infection, intra-abdominal infection and nosocomial pneumonia and any other indication were reported. |
| Baseline (before the initiation of initial antibiotic therapy) |
| Dose of Ceftazidime - Avibactam | In this outcome measure dose (median of daily dose) of ceftazidime-avibactam was reported till Day 14 or End of treatment whichever was earlier. | Up to Day 14 or End of treatment after ceftazidime-avibactam initiation, whichever was earlier |
| Number of Participants According to Frequency of Administration | Number of participants according to frequency of administration (twice daily [BID], once daily [OD] and thrice daily [TID]) of ceftazidime-avibactam is reported in this outcome measure. | Up to Day 14 or End of treatment after ceftazidime-avibactam initiation, whichever was earlier |
| Duration of Administration of Ceftazidime - Avibactam | Up to Day 14 or End of treatment after ceftazidime-avibactam initiation, whichever was earlier |
| Total Duration of Therapy of Ceftazidime-Avibactam | Up to Day 14 or End of treatment after ceftazidime-avibactam initiation, whichever was earlier |
| Number of Participants Who Received Concomitant Antibiotics With Ceftazidime-Avibactam | Up to Day 14 or End of treatment after ceftazidime-avibactam initiation, whichever was earlier |
| Number of Participants With History of Antibiotic Exposure | 90 days prior to current hospital admission |
| Number of Participants According to Identified Gram Negative Organisms | In this outcome measure, the gram-negative organisms identified at baseline was reported. One participant could have more than one gram-negative bacteria identified. | Baseline (before the initiation of initial antibiotic therapy) |
| Number of Participants With Identified Pathogens Susceptible to Ceftazidime-Avibactam | Baseline (before the initiation of initial antibiotic therapy) |
| Duration of Hospital Stay | Duration of hospital stay was calculated based on 1) total number of consecutive days the participant was treated in the hospital from admission to discharge during their initial hospitalization; 2) the total number of days of hospitalization between diagnosis of infection and discharge; 3) the total number of days the participant was treated in the hospital after ceftazidime-avibactam initiation up to hospital discharge, including the first day of treatment. | Up to 30 days post treatment completion, death or discharge; whichever was first (Up to maximum of 49 days) |
| Duration of Stay in Intensive Care Unit (ICU) | Intensive care unit length of stay was calculated based on 1) the total number of consecutive or non-consecutive days the participant was treated in the ICU during their initial hospitalization; and 2) the total number of days the participant was treated in the ICU after ceftazidime-avibactam initiation, including the first day of treatment. | Up to 30 days post treatment completion, death or discharge; whichever was first (Up to maximum of 49 days) |
| Number of Participants According to Healthcare Resource Utilization | In this outcome measure number of participants were reported as per their healthcare resource utilization data, abstracted from the participant medical records. Healthcare resources included: mechanical ventilation, computed tomography (CT)/magnetic resonance imaging (MRI), tracheostomy, hemodialysis, surgical intervention, percutaneous procedures and other procedures. | Up to 30 days post treatment completion with ceftazidime-avibactam death or discharge; whichever was first (Up to maximum of 49 days) |
| Number of Participants With Recurrence of Infection | Number of participants with recurrence of infection during hospital stay, including re-infection and relapse up to 30 days post treatment completion with ceftazidime-avibactam, death or discharge; whichever occurred first was summarized in this outcome measure. | Up to 30 days post treatment completion with ceftazidime-avibactam, death or discharge; whichever was first (Up to maximum of 49 days) |
| Chennai |
| 600006 |
| India |
| Gleneagles Global Hospitals | Chennai | 600100 | India |
| Deenanath Mangeshkar Hospital and Research Centre | Erandwane,, PUNE | 411004 | India |
| Apollo Hospital | Hyderabad | HYDERABAD | India |
| Metro Hospital | Noida | 201301 | India |
| Grant Medical Foundation Ruby Hall Clinic | Pune | 411001 | India |
| Amri Hospital | WEST Bengal | 700098 | India |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Number of Participants With Treatment Success at Day 7 | The treatment success was defined as resolution of all signs and symptoms of the infection based on the clinician's judgment and the treatment protocol/algorithm followed at the respective centers. The treatment success in terms of clinical outcome was classified as clinical success (resolution of all signs and symptoms of the infection), clinical failure (persistence of signs and symptoms from baseline) and indeterminate (there is not enough information to conclude whether the antibiotic regimen containing ceftazidime-avibactam was a clinical failure or a success). | Analysis population included all participants who received ceftazidime-avibactam for at least 48 hours. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | Day 7 after ceftazidime-avibactam initiation |
|
|
|
| Primary | Number of Participants With Treatment Success at Day 14 or End of Treatment | The treatment success was defined as resolution of all signs and symptoms of the infection based on the clinician's judgment and the treatment protocol/algorithm followed at the respective centers. The treatment success in terms of clinical outcome was classified as clinical success (resolution of all signs and symptoms of the infection), clinical failure (persistence of signs and symptoms from baseline) and indeterminate (there is not enough information to conclude whether the antibiotic regimen containing ceftazidime-avibactam was a clinical failure or a success). | Analysis population included all participants who received ceftazidime-avibactam for at least 48 hours. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | Day 14 or End of Treatment after ceftazidime-avibactam initiation, whichever was earlier |
|
|
|
| Primary | Number of Participants With Microbiological Success at Day 7 | Microbiological success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication) and repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication). | Analysis population included all participants who received ceftazidime-avibactam for at least 48 hours. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | Day 7 after ceftazidime-avibactam initiation |
|
|
|
| Primary | Number of Participants With Microbiological Success at Day 14 or End of Treatment | Microbiological success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication) and repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication). | Analysis population included all participants who received ceftazidime-avibactam for at least 48 hours. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | Day 14 or End of Treatment after ceftazidime-avibactam initiation, whichever was earlier |
|
|
|
| Secondary | Number of Participants Classified According to Source of Infection at Baseline for Which Ceftazidime-Avibactam Was Used | Source of infection included hospital-acquired infection, healthcare-associated infection, and community-acquired infection. | Analysis population included all participants who received ceftazidime-avibactam for at least 48 hours. | Posted | Count of Participants | Participants | Baseline (before initiation of initial antibiotic therapy) |
|
|
|
| Secondary | Number of Participants According to Indication at Baseline for Which Ceftazidime-Avibactam Was Used | The indications for use of ceftazidime-avibactam at baseline including urinary tract infection, intra-abdominal infection and nosocomial pneumonia and any other indication were reported. | Analysis population included all participants who received ceftazidime-avibactam for at least 48 hours. | Posted | Count of Participants | Participants | Baseline (before the initiation of initial antibiotic therapy) |
|
|
|
| Secondary | Dose of Ceftazidime - Avibactam | In this outcome measure dose (median of daily dose) of ceftazidime-avibactam was reported till Day 14 or End of treatment whichever was earlier. | Analysis population included all participants who received ceftazidime-avibactam for at least 48 hours. | Posted | Median | Full Range | Milligrams | Up to Day 14 or End of treatment after ceftazidime-avibactam initiation, whichever was earlier |
|
|
|
| Secondary | Number of Participants According to Frequency of Administration | Number of participants according to frequency of administration (twice daily [BID], once daily [OD] and thrice daily [TID]) of ceftazidime-avibactam is reported in this outcome measure. | Analysis population included all participants who received ceftazidime-avibactam for at least 48 hours. | Posted | Count of Participants | Participants | Up to Day 14 or End of treatment after ceftazidime-avibactam initiation, whichever was earlier |
|
|
|
| Secondary | Duration of Administration of Ceftazidime - Avibactam | Analysis population included all participants who received ceftazidime-avibactam for at least 48 hours. | Posted | Mean | Standard Deviation | Hours | Up to Day 14 or End of treatment after ceftazidime-avibactam initiation, whichever was earlier |
|
|
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| Secondary | Total Duration of Therapy of Ceftazidime-Avibactam | Analysis population included all participants who received ceftazidime-avibactam for at least 48 hours. | Posted | Mean | Standard Deviation | Days | Up to Day 14 or End of treatment after ceftazidime-avibactam initiation, whichever was earlier |
|
|
|
| Secondary | Number of Participants Who Received Concomitant Antibiotics With Ceftazidime-Avibactam | Analysis population included all participants who received ceftazidime-avibactam for at least 48 hours. | Posted | Count of Participants | Participants | Up to Day 14 or End of treatment after ceftazidime-avibactam initiation, whichever was earlier |
|
|
|
| Secondary | Number of Participants With History of Antibiotic Exposure | Analysis population included all participants who received ceftazidime-avibactam for at least 48 hours. | Posted | Count of Participants | Participants | 90 days prior to current hospital admission |
|
|
|
| Secondary | Number of Participants According to Identified Gram Negative Organisms | In this outcome measure, the gram-negative organisms identified at baseline was reported. One participant could have more than one gram-negative bacteria identified. | Analysis population included all participants who received ceftazidime-avibactam for at least 48 hours. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | Baseline (before the initiation of initial antibiotic therapy) |
|
|
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| Secondary | Number of Participants With Identified Pathogens Susceptible to Ceftazidime-Avibactam | Analysis population included all participants who received ceftazidime-avibactam for at least 48 hours. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | Baseline (before the initiation of initial antibiotic therapy) |
|
|
|
| Secondary | Duration of Hospital Stay | Duration of hospital stay was calculated based on 1) total number of consecutive days the participant was treated in the hospital from admission to discharge during their initial hospitalization; 2) the total number of days of hospitalization between diagnosis of infection and discharge; 3) the total number of days the participant was treated in the hospital after ceftazidime-avibactam initiation up to hospital discharge, including the first day of treatment. | Analysis population included all participants who received ceftazidime-avibactam for at least 48 hours. | Posted | Mean | Standard Deviation | Days | Up to 30 days post treatment completion, death or discharge; whichever was first (Up to maximum of 49 days) |
|
|
|
| Secondary | Duration of Stay in Intensive Care Unit (ICU) | Intensive care unit length of stay was calculated based on 1) the total number of consecutive or non-consecutive days the participant was treated in the ICU during their initial hospitalization; and 2) the total number of days the participant was treated in the ICU after ceftazidime-avibactam initiation, including the first day of treatment. | Analysis population included all participants who received ceftazidime-avibactam for at least 48 hours. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Days | Up to 30 days post treatment completion, death or discharge; whichever was first (Up to maximum of 49 days) |
|
|
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| Secondary | Number of Participants According to Healthcare Resource Utilization | In this outcome measure number of participants were reported as per their healthcare resource utilization data, abstracted from the participant medical records. Healthcare resources included: mechanical ventilation, computed tomography (CT)/magnetic resonance imaging (MRI), tracheostomy, hemodialysis, surgical intervention, percutaneous procedures and other procedures. | Analysis population included all participants who received ceftazidime-avibactam for at least 48 hours. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | Up to 30 days post treatment completion with ceftazidime-avibactam death or discharge; whichever was first (Up to maximum of 49 days) |
|
|
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| Secondary | Number of Participants With Recurrence of Infection | Number of participants with recurrence of infection during hospital stay, including re-infection and relapse up to 30 days post treatment completion with ceftazidime-avibactam, death or discharge; whichever occurred first was summarized in this outcome measure. | Analysis population included all participants who received ceftazidime-avibactam for at least 48 hours. | Posted | Count of Participants | Participants | Up to 30 days post treatment completion with ceftazidime-avibactam, death or discharge; whichever was first (Up to maximum of 49 days) |
|
|
|
| Primary | Number of Participants With Serious Adverse Events and Non-Serious Adverse Events With Explicit Attribution to Ceftazidime-Avibactam | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. All AEs that did not meet the criteria for "serious" were considered as non-serious. Adverse events with explicit attribution to any Pfizer drug that appeared in the reviewed information (defined per the participant population and study period specified in the protocol) were reported. Explicit attribution was not inferred by temporal relationship between drug administration and an AE, but was based on a causality assessed by a healthcare provider linking drug administration and AE. | Analysis population included all participants who received ceftazidime-avibactam for at least 48 hours. | Posted | Count of Participants | Participants | Up to 30 days post treatment completion with ceftazidime-avibactam, death or discharge; whichever was first (Up to maximum of 49 days) |
|
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| 0 |
| 189 |
| 0 |
| 189 |
| 0 |
| 189 |
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications 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.
| Others |
|
| Title | Measurements |
|---|---|
|
| Klebsiella species |
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| Enterobacter species |
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| Enterobacter cloacae |
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| Proteus mirabilis |
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| Pseudomonas species |
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| Other |
|
| Title | Measurements |
|---|---|
|
| Hemodialysis |
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| Surgical intervention |
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| Percutaneous procedures |
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| Other procedure (Other healthcare resources utilized) |
|