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This is a prospective, single arm, open-label, multi-center clinical study evaluating the effectiveness and safety of CAZ-AVI in participants with HAP (including VAP), who have initiated treatment with CAZ-AVI in an inpatient hospital setting. The duration of antibiotic treatment with the CAZ-AVI is 7-14 days. Participants must receive intravenously (IV) CAZ-AVI in the hospital for at least 7 full days. There are no formal hypothesis tests planned for this study. The number and percent of participants having clinical cure, failure, and indeterminate at TOC visit in the cMITT analysis population will be summarized.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAZ-AVI | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zavicefta, Ceftazidime-Avibactam | Drug | Participants will receive CAZ-AVI (2000 mg of ceftazidime and 500 mg of avibactam) administered by IV infusion in a volume of 100 mL at a constant rate over 2 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Clinical Cure at Test of Cure (TOC) Visit: Clinical Modified Intent-to-Treat (cMITT) Population | Clinical cure: participants were considered to be a success for clinical response at TOC visit if the participants were not a clinical failure at end of treatment (EOT), and the participants were alive and all signs and symptoms of pneumonia were resolved or improved to an extent that no antibacterial therapy for HAP was taken between EOT and TOC inclusive. Gram negative is abbreviated as gram -ve and gram positive as gram +ve. | TOC visit: any day from Day 21 to 25 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Clinical Cure at EOT Visit: cMITT Population | Clinical cure: participants were considered to be a success for clinical response at EOT visit if the participants were alive and all signs and symptoms of pneumonia were resolved or improved such that all antibacterial therapies for HAP/ VAP were stopped. No antibacterial therapy other than those outlined by the protocol was administered for HAP prior to EOT. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuyang People's Hospital | Fuyang | Anhui | 236000 | China | ||
| Peking University Third 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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A total of 235 Chinese adult participants with hospital acquired pneumonia (HAP) [including ventilator-associated pneumonia {VA}] were enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ceftazidime-Avibactam (CAZ-AVI) | Participants received CAZ-AVI (Zavicefta), 2.5 grams (g) [ceftazidime 2g + avibactam 0.5g], intravenously (IV) as 2 hours infusion every 8 hours for a minimum of 7 days and a maximum of 14 days. Participants were followed up to maximum of 32 days after the last dose of study intervention. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Feb 7, 2022 | Apr 12, 2024 |
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| EOT visit: within 24 hours after the completion of the last infusion of study intervention (study treatment was a minimum of 7 days and maximum of 14 days) |
| Percentage of Participants With Clinical Cure at EOT and TOC Visit: Microbiological Modified Intent-to-Treat (mMITT) Population | Clinical cure at EOT: participants were considered to be a success for clinical response at EOT visit if the participants were alive and all signs and symptoms of pneumonia were resolved or improved such that all antibacterial therapies for HAP/VAP were stopped. No antibacterial therapy other than those outlined by the protocol was administered for HAP prior to EOT. Clinical cure at TOC: participants were considered to be a success for clinical response at TOC visit if the participants were not a clinical failure at EOT, and the participants were alive and all signs and symptoms of pneumonia were resolved or improved to an extent that no antibacterial therapy for HAP was taken between EOT and TOC inclusive. | EOT visit: within 24 hours after the completion of the last infusion of study intervention (study treatment was a minimum of 7 days and maximum of 14 days); TOC visit: any day from Day 21 to 25 |
| Percentage of Participants With Favorable Per-Participant Microbiological Response at the EOT and TOC Visits: mMITT Population | For participants from whom only 1 causative pathogen is isolated, the overall microbiological response assessment was based on the microbiological response assessment for that pathogen. For participants from whom more than 1 baseline pathogen was isolated, the overall microbiological response assessment was "favorable" only if the microbiological response assessment for each of the baseline pathogens isolated was "favorable". Favorable microbiological response included eradication (an adequate source specimen demonstrated absence of the original baseline pathogen) and presumed eradication (an adequate source specimen was not available to culture and the participant was assessed as a clinical cure). In this outcome measure percentage of participants with favorable per-participant microbiological response are recorded. | EOT visit: within 24 hours after the completion of the last infusion of study intervention (study treatment was a minimum of 7 days and maximum of 14 days); TOC visit: any day from Day 21 to 25 |
| Percentage of Participants With Favorable Per-Pathogen Microbiological Response at the EOT and TOC Visits: mMITT Population | Favorable microbiological response included eradication (an adequate source specimen demonstrated absence of the original baseline pathogen) and presumed eradication (an adequate source specimen was not available to culture and the participant was assessed as a clinical cure). In this outcome measure percentage of participants with favorable per-pathogen microbiological response are recorded. | EOT visit: within 24 hours after the completion of the last infusion of study intervention (study treatment was a minimum of 7 days and maximum of 14 days); TOC visit: any day from Day 21 to 25 |
| Percentage of Participants With Clinical Cure at the EOT and TOC Visits in Participants With Gram-negative Baseline Pathogens Resistant to Ceftazidime: mMITT Population | Clinical cure at EOT: participants were considered to be a success for clinical response at EOT visit if the participants were alive and all signs and symptoms of pneumonia were resolved or improved such that all antibacterial therapies for HAP/VAP were stopped. No antibacterial therapy other than those outlined by the protocol was administered for HAP prior to EOT. Clinical cure at TOC: participants were considered to be a success for clinical response at TOC visit if the participants were not a clinical failure at EOT, and the participants were alive and all signs and symptoms of pneumonia were resolved or improved to an extent that no antibacterial therapy for HAP was taken between EOT and TOC inclusive. | EOT visit: within 24 hours after the completion of the last infusion of study intervention (study treatment was a minimum of 7 days and maximum of 14 days); TOC visit: any day from Day 21 to 25 |
| Percentage of Participants With Favorable Per-Participant Microbiologic Response at the EOT and TOC Visits in Participants With Gram-negative Baseline Pathogens Resistant to Ceftazidime: mMITT Population | For participants from whom only 1 causative pathogen is isolated, the overall microbiological response assessment was based on the microbiological response assessment for that pathogen. For participants from whom more than 1 baseline pathogen was isolated, the overall microbiological response assessment was "favorable" only if the microbiological response assessment for each of the baseline pathogens isolated was "favorable". Favorable microbiological response included eradication (an adequate source specimen demonstrated absence of the original baseline pathogen) and presumed eradication (an adequate source specimen was not available to culture and the participant was assessed as a clinical cure). In this outcome measure percentage of participants with favorable per-participant microbiological response are recorded. | EOT visit: within 24 hours after the completion of the last infusion of study intervention (study treatment was a minimum of 7 days and maximum of 14 days); TOC visit: any day from Day 21 to 25 |
| Percentage of Participants With Death Due to Any Cause at the TOC Visit and at Day 28 Visit: cMITT Population | TOC visit: any day from Day 21 to 25; Day 28 |
| Percentage of Participants With Death Due to Any Cause at the TOC Visit and at Day 28 Visit: mMITT Population | TOC visit: any day from Day 21 to 25; Day 28 |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and all non-SAEs that occurred in the study. TEAEs were AEs between first dose of study treatment and up to 32 days post last dose that were absent before treatment or that worsened relative to pretreatment state. | Day 1 up to 32 days after last dose of CAZ-AVI (maximum up to 46 days; maximum treatment duration was of 14 days) |
| Number of Participants With Clinically Significant Post-Baseline Laboratory Test Abnormalities | Hematology: Hemoglobin (Hg), hematocrit, erythrocytes: less than (<)0.8*lower limit of normal (LLN) & change (chg) more than (>)20% decrease (dec); platelets: <0.65*LLN & chg >50% dec &, >1.5* upper limit of normal (ULN) & chg >100% increase (inc); leukocytes: <0.65*LLN & chg >60% dec &, >1.6*ULN & chg >100% inc; lymphocytes, <0.25*LLN & chg >75% dec; neutrophils: <0.65*LLN & chg >75% dec &, >1.6*ULN & chg >100% inc; basophils, monocytes: >4.0* ULN & chg >300% inc. Clinical chemistry: bilirubin: >2.0*ULN & chg >150% inc; aspartate aminotransferase (AT) & Alanine AT: >3.0*ULN & chg >200% inc; alkaline phosphatase <0.5*LLN & chg >80% dec & >2.0*ULN & chg >100% inc; creatinine: >2.0*ULN & >chg 100% inc; sodium: <0.85*LLN & chg >10% dec & >1.1*ULN & chg >10% inc; potassium & chloride: <0.8*LLN & chg >20% dec & >1.2*ULN & chg >20% dec; calcium: <0.7*LLN & chg >30% dec & bicarbonate: <0.7*LLN & chg >40% dec. Clinical significance was judged by investigator. | Day 1 up to 32 days after last dose of CAZ-AVI (maximum up to 46 days; maximum treatment duration was of 14 days) |
| Number of Participants With Vital Signs Data According to Pre-defined Criteria | Vital signs included diastolic blood pressure (millimeters of mercury [mmHg]); pulse rate (beats per minute [bpm]) and systolic blood pressure (mmHg). Pre-defined criteria: Diastolic blood pressure: Value <50 mmHg, Diastolic blood pressure: Change more than or equal to (>=) 20 mmHg increase, Diastolic blood pressure: Change >= 20 mmHg decrease, Pulse rate: Value <40 bpm, Pulse rate: Value >120 bpm, Systolic blood pressure: Value <90 mmHg, Systolic blood pressure: Change >= 30 mmHg increase, Systolic blood pressure: Change >= 30 mmHg decrease. One participant could have more than one vital sign abnormality. | Day 1 up to 32 days after last dose of CAZ-AVI (maximum up to 46 days; maximum treatment duration was of 14 days) |
| Beijing |
| Beijing Municipality |
| 100191 |
| China |
| The First Affiliated Hospital of Fujian Medical University | Fuzhou | Fujian | 350005 | China |
| Zhongshan Hospital Xiamen University | Xiamen | Fujian | 361004 | China |
| Guangzhou First People's Hospital | Guangzhou | Guangdong | 510180 | China |
| ZhuJiang Hospital of Southern Medical University | Guangzhou | Guangdong | 510280 | China |
| The First Affiliated Hospital of Jinan University | Guangzhou | Guangdong | 510630 | China |
| Huizhou Central People's Hospital | Huizhou | Guangdong | 516008 | China |
| Qingyuan People's Hospital | Qingyuan | Guangdong | 511500 | China |
| Shenzhen People's Hospital | Shenzhen | Guangdong | 518020 | China |
| The Second People's Hospital of Shenzhen | Shenzhen | Guangdong | 518035 | China |
| Affiliated Hospital of Guangdong Medical University | Zhanjiang | Guangdong | 524000 | China |
| Central People's Hospital of Zhanjiang | Zhanjiang | Guangdong | 524045 | China |
| The First People's Hospital of Nanning | Nanning | Guangxi | 530022 | China |
| The Affiliated Hospital of Zunyi Medical University | Zunyi | Guizhou | 563000 | China |
| Hainan General Hospital | Haikou | Hainan | 570311 | China |
| Sanya People's Hospital | Sanya | Hainan | 572022 | China |
| Affiliated Hospital of Hebei University | Baoding | Hebei | 071000 | China |
| Luoyang Central Hospital | Luoyang | Henan | 471009 | China |
| NanYang central hospital | Nanyang | Henan | 473000 | China |
| NanYang First people's hospital | Nanyang | Henan | 47300 | China |
| Henan provincial people's hospital | Zhengzhou | Henan | 450003 | China |
| Shiyan Renmin Hospital | Shiyan | Hubei | 442000 | China |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | 430058 | China |
| Renmin Hospital of Wuhan University | Wuhan | Hubei | 430060 | China |
| Hunan Provincial People's Hospital | Changsha | Hunan | 410005 | China |
| Yueyang People's Hospital | Yueyang | Hunan | 414020 | China |
| Baotou Central Hospital | Baotou | Inner Mongolia | 014000 | China |
| Baotou Central Hospital | Baotou | Inner Mongolia | 014040 | China |
| Huai'an First People's Hospital | Huai'an | Jiangsu | 223300 | China |
| Jiangyin People's Hospital | Jiangyin | Jiangsu | 214400 | China |
| The First People's Hospital of Lianyungang City | Lianyungang | Jiangsu | 222002 | China |
| Taizhou People's Hospital | Taizhou | Jiangsu | 225300 | China |
| Affiliated Hospital of Jiangnan University | Wuxi | Jiangsu | 214122 | China |
| The Affiliated Hospital of Xuzhou Medical University | Xuzhou | Jiangsu | 221002 | China |
| Subei People's Hospital of Jiangsu province | Yangzhou | Jiangsu | 225001 | China |
| Jiangxi Provincial People's Hospital | Nanchang | Jiangxi | 330038 | China |
| Affiliated Zhongshan Hospital of Dalian University | Dalian | Liaoning | 116001 | China |
| General Hospital of Northern Theater Command | Shenyang | Liaoning | 110016 | China |
| General Hospital of Ningxia Medical University | Yinchuan | Ningxia | 750004 | China |
| Huashan Hospital Fudan University | Shanghai | Shanghai Municipality | 200040 | China |
| West China Hospital of Sichuan University | Chengdu | Sichuan | 610041 | China |
| Chengdu Xinhua Hospital | Chengdu | Sichuan | 610055 | China |
| Tianjin Medical University General Hospital | Tianjin | Tianjin Municipality | 300052 | China |
| Tianjin Chest Hospital | Tianjin | Tianjin Municipality | 300222 | China |
| The First Hospital of Kunming | Kunming | Yunnan | 650034 | China |
| Dongyang People's Hospital | Dongyang | Zhejiang | 322199 | China |
| Zhejiang Hospital | Hangzhou | Zhejiang | 310013 | China |
| Zhejiang Provincial People's Hospital | Hangzhou | Zhejiang | 310014 | China |
| Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University | Hangzhou | Zhejiang | 310016 | China |
| Zhejiang Hospital | Hangzhou | Zhejiang | 310030 | China |
| The 2nd Affiliated Hospital of WMU | Wenzhou | Zhejiang | 325035 | China |
| Wenzhou Central Hospital | Wenzhou | Zhejiang | 325099 | China |
| Seventh Medical Center, The General Hospital of People's Liberation Army | Beijing | China |
| Shanghai Fifth People's Hospital, Fudan University | Shanghai | 200240 | China |
| Zhongshan Hospital Xiamen University | Xiamen | China |
| COMPLETED |
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| NOT COMPLETED |
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Safety analysis set (SAS) included all participants who had taken at least 1 dose of study intervention.
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| ID | Title | Description |
|---|---|---|
| BG000 | CAZ-AVI 1 | Participants received CAZ-AVI (Zavicefta), 2.5 g (ceftazidime 2g + avibactam 0.5g), IV as 2 hours infusion every 8 hours for a minimum of 7 days and a maximum of 14 days. Participants were followed up to maximum of 32 days after the last dose of study intervention. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 | Percentage of Participants With Clinical Cure at Test of Cure (TOC) Visit: Clinical Modified Intent-to-Treat (cMITT) Population | Clinical cure: participants were considered to be a success for clinical response at TOC visit if the participants were not a clinical failure at end of treatment (EOT), and the participants were alive and all signs and symptoms of pneumonia were resolved or improved to an extent that no antibacterial therapy for HAP was taken between EOT and TOC inclusive. Gram negative is abbreviated as gram -ve and gram positive as gram +ve. | cMITT: MITT subset and participants whose baseline respiratory or blood culture showed gram -ve pathogens with or without concomitant gram +ve pathogens (excluding those with gram -ve pathogens unexpected to respond to either study drug [participants with only monomicrobial gram -ve infection: any Acinetobacter species/ Legionella species/ Stenotrophomonas maltophilia/ Elizabethkingia meningoseptica]) or in whom no etiologic pathogens identified from respiratory or blood culture at baseline. | Posted | Number | 95% Confidence Interval | Percentage of participants | TOC visit: any day from Day 21 to 25 |
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| Secondary | Percentage of Participants With Clinical Cure at EOT Visit: cMITT Population | Clinical cure: participants were considered to be a success for clinical response at EOT visit if the participants were alive and all signs and symptoms of pneumonia were resolved or improved such that all antibacterial therapies for HAP/ VAP were stopped. No antibacterial therapy other than those outlined by the protocol was administered for HAP prior to EOT. | cMITT: MITT subset and participants whose baseline respiratory or blood culture showed gram -ve pathogens with or without concomitant gram +ve pathogens (excluding those with gram -ve pathogens unexpected to respond to either study drug [participants with only monomicrobial gram -ve infection: any Acinetobacter species/ Legionella species/ Stenotrophomonas maltophilia/ Elizabethkingia meningoseptica]) or in whom no etiologic pathogens identified from respiratory or blood culture at baseline. | Posted | Number | 95% Confidence Interval | Percentage of participants | EOT visit: within 24 hours after the completion of the last infusion of study intervention (study treatment was a minimum of 7 days and maximum of 14 days) |
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| Secondary | Percentage of Participants With Clinical Cure at EOT and TOC Visit: Microbiological Modified Intent-to-Treat (mMITT) Population | Clinical cure at EOT: participants were considered to be a success for clinical response at EOT visit if the participants were alive and all signs and symptoms of pneumonia were resolved or improved such that all antibacterial therapies for HAP/VAP were stopped. No antibacterial therapy other than those outlined by the protocol was administered for HAP prior to EOT. Clinical cure at TOC: participants were considered to be a success for clinical response at TOC visit if the participants were not a clinical failure at EOT, and the participants were alive and all signs and symptoms of pneumonia were resolved or improved to an extent that no antibacterial therapy for HAP was taken between EOT and TOC inclusive. | mMITT:MITT subset and participants with proper respiratory culture (RC) showing gram-ve pathogens,excluding participants unexpected to respond to CAZ-AVI (participants with only monomicrobial gram-ve infections:any Acinetobacter species/Legionella species/Stenotrophomonas maltophilia/Elizabethkingia meningoseptica).If baseline RC unavailable or didn't identify respiratory pathogen, but gram-ve organism causing pneumonia was identified from baseline blood cultures,participant qualified for mMITT. | Posted | Number | 95% Confidence Interval | Percentage of participants | EOT visit: within 24 hours after the completion of the last infusion of study intervention (study treatment was a minimum of 7 days and maximum of 14 days); TOC visit: any day from Day 21 to 25 |
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| Secondary | Percentage of Participants With Favorable Per-Participant Microbiological Response at the EOT and TOC Visits: mMITT Population | For participants from whom only 1 causative pathogen is isolated, the overall microbiological response assessment was based on the microbiological response assessment for that pathogen. For participants from whom more than 1 baseline pathogen was isolated, the overall microbiological response assessment was "favorable" only if the microbiological response assessment for each of the baseline pathogens isolated was "favorable". Favorable microbiological response included eradication (an adequate source specimen demonstrated absence of the original baseline pathogen) and presumed eradication (an adequate source specimen was not available to culture and the participant was assessed as a clinical cure). In this outcome measure percentage of participants with favorable per-participant microbiological response are recorded. | mMITT:MITT subset and participants with proper RC showing gram-ve pathogens,excluding participants unexpected to respond to CAZ-AVI (participants with only monomicrobial gram-ve infections:any Acinetobacter species/Legionella species/Stenotrophomonas maltophilia/Elizabethkingia meningoseptica).If baseline RC unavailable or didn't identify respiratory pathogen, but gram-ve organism causing pneumonia was identified from baseline blood cultures,participant qualified for mMITT. | Posted | Number | 95% Confidence Interval | Percentage of participants | EOT visit: within 24 hours after the completion of the last infusion of study intervention (study treatment was a minimum of 7 days and maximum of 14 days); TOC visit: any day from Day 21 to 25 |
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| Secondary | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at the EOT and TOC Visits: mMITT Population | Favorable microbiological response included eradication (an adequate source specimen demonstrated absence of the original baseline pathogen) and presumed eradication (an adequate source specimen was not available to culture and the participant was assessed as a clinical cure). In this outcome measure percentage of participants with favorable per-pathogen microbiological response are recorded. | mMITT analysis set evaluated. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants in mMITT analysis set evaluable for specified pathogens and visits. | Posted | Number | 95% Confidence Interval | Percentage of participants | EOT visit: within 24 hours after the completion of the last infusion of study intervention (study treatment was a minimum of 7 days and maximum of 14 days); TOC visit: any day from Day 21 to 25 |
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| Secondary | Percentage of Participants With Clinical Cure at the EOT and TOC Visits in Participants With Gram-negative Baseline Pathogens Resistant to Ceftazidime: mMITT Population | Clinical cure at EOT: participants were considered to be a success for clinical response at EOT visit if the participants were alive and all signs and symptoms of pneumonia were resolved or improved such that all antibacterial therapies for HAP/VAP were stopped. No antibacterial therapy other than those outlined by the protocol was administered for HAP prior to EOT. Clinical cure at TOC: participants were considered to be a success for clinical response at TOC visit if the participants were not a clinical failure at EOT, and the participants were alive and all signs and symptoms of pneumonia were resolved or improved to an extent that no antibacterial therapy for HAP was taken between EOT and TOC inclusive. | mMITT analysis set evaluated. Here, "Overall Number of Participants Analyzed" signifies number of participants who were evaluable for this outcome measure, i.e. participants in mMITT analysis set that with gram-negative baseline pathogens resistant to ceftazidime. | Posted | Number | 95% Confidence Interval | Percentage of participants | EOT visit: within 24 hours after the completion of the last infusion of study intervention (study treatment was a minimum of 7 days and maximum of 14 days); TOC visit: any day from Day 21 to 25 |
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| Secondary | Percentage of Participants With Favorable Per-Participant Microbiologic Response at the EOT and TOC Visits in Participants With Gram-negative Baseline Pathogens Resistant to Ceftazidime: mMITT Population | For participants from whom only 1 causative pathogen is isolated, the overall microbiological response assessment was based on the microbiological response assessment for that pathogen. For participants from whom more than 1 baseline pathogen was isolated, the overall microbiological response assessment was "favorable" only if the microbiological response assessment for each of the baseline pathogens isolated was "favorable". Favorable microbiological response included eradication (an adequate source specimen demonstrated absence of the original baseline pathogen) and presumed eradication (an adequate source specimen was not available to culture and the participant was assessed as a clinical cure). In this outcome measure percentage of participants with favorable per-participant microbiological response are recorded. | mMITT analysis set evaluated. Here, "Overall Number of Participants Analyzed" signifies number of participants who were evaluable for this outcome measure, i.e. participants in mMITT analysis set that with gram-negative baseline pathogens resistant to ceftazidime. | Posted | Number | 95% Confidence Interval | Percentage of participants | EOT visit: within 24 hours after the completion of the last infusion of study intervention (study treatment was a minimum of 7 days and maximum of 14 days); TOC visit: any day from Day 21 to 25 |
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| Secondary | Percentage of Participants With Death Due to Any Cause at the TOC Visit and at Day 28 Visit: cMITT Population | cMITT: MITT subset and participants whose baseline respiratory or blood culture showed gram -ve pathogens with or without concomitant gram +ve pathogens (excluding those with gram -ve pathogens unexpected to respond to either study drug [participants with only monomicrobial gram -ve infection: any Acinetobacter species/ Legionella species/ Stenotrophomonas maltophilia/ Elizabethkingia meningoseptica]) or in whom no etiologic pathogens identified from respiratory or blood culture at baseline. | Posted | Number | 95% Confidence Interval | Percentage of participants | TOC visit: any day from Day 21 to 25; Day 28 |
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| Secondary | Percentage of Participants With Death Due to Any Cause at the TOC Visit and at Day 28 Visit: mMITT Population | mMITT:MITT subset and participants with proper RC showing gram-ve pathogens,excluding participants unexpected to respond to CAZ-AVI (participants with only monomicrobial gram-ve infections:any Acinetobacter species/Legionella species/Stenotrophomonas maltophilia/Elizabethkingia meningoseptica).If baseline RC unavailable or didn't identify respiratory pathogen, but gram-ve organism causing pneumonia was identified from baseline blood cultures,participant qualified for mMITT. | Posted | Number | 95% Confidence Interval | Percentage of participants | TOC visit: any day from Day 21 to 25; Day 28 |
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| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and all non-SAEs that occurred in the study. TEAEs were AEs between first dose of study treatment and up to 32 days post last dose that were absent before treatment or that worsened relative to pretreatment state. | SAS included all participants who had taken at least 1 dose of study intervention. | Posted | Count of Participants | Participants | Day 1 up to 32 days after last dose of CAZ-AVI (maximum up to 46 days; maximum treatment duration was of 14 days) |
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| Secondary | Number of Participants With Clinically Significant Post-Baseline Laboratory Test Abnormalities | Hematology: Hemoglobin (Hg), hematocrit, erythrocytes: less than (<)0.8*lower limit of normal (LLN) & change (chg) more than (>)20% decrease (dec); platelets: <0.65*LLN & chg >50% dec &, >1.5* upper limit of normal (ULN) & chg >100% increase (inc); leukocytes: <0.65*LLN & chg >60% dec &, >1.6*ULN & chg >100% inc; lymphocytes, <0.25*LLN & chg >75% dec; neutrophils: <0.65*LLN & chg >75% dec &, >1.6*ULN & chg >100% inc; basophils, monocytes: >4.0* ULN & chg >300% inc. Clinical chemistry: bilirubin: >2.0*ULN & chg >150% inc; aspartate aminotransferase (AT) & Alanine AT: >3.0*ULN & chg >200% inc; alkaline phosphatase <0.5*LLN & chg >80% dec & >2.0*ULN & chg >100% inc; creatinine: >2.0*ULN & >chg 100% inc; sodium: <0.85*LLN & chg >10% dec & >1.1*ULN & chg >10% inc; potassium & chloride: <0.8*LLN & chg >20% dec & >1.2*ULN & chg >20% dec; calcium: <0.7*LLN & chg >30% dec & bicarbonate: <0.7*LLN & chg >40% dec. Clinical significance was judged by investigator. | SAS included all participants who had taken at least 1 dose of study intervention. Here "Number of Participants Analyzed" includes number of participants evaluable for laboratory abnormalities. | Posted | Count of Participants | Participants | Day 1 up to 32 days after last dose of CAZ-AVI (maximum up to 46 days; maximum treatment duration was of 14 days) |
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| Secondary | Number of Participants With Vital Signs Data According to Pre-defined Criteria | Vital signs included diastolic blood pressure (millimeters of mercury [mmHg]); pulse rate (beats per minute [bpm]) and systolic blood pressure (mmHg). Pre-defined criteria: Diastolic blood pressure: Value <50 mmHg, Diastolic blood pressure: Change more than or equal to (>=) 20 mmHg increase, Diastolic blood pressure: Change >= 20 mmHg decrease, Pulse rate: Value <40 bpm, Pulse rate: Value >120 bpm, Systolic blood pressure: Value <90 mmHg, Systolic blood pressure: Change >= 30 mmHg increase, Systolic blood pressure: Change >= 30 mmHg decrease. One participant could have more than one vital sign abnormality. | SAS included all participants who had taken at least 1 dose of study intervention. | Posted | Count of Participants | Participants | Day 1 up to 32 days after last dose of CAZ-AVI (maximum up to 46 days; maximum treatment duration was of 14 days) |
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Day 1 up to 32 days after last dose of CAZ-AVI (maximum up to 46 days; maximum treatment duration was of 14 days)
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Non-SAES are reported at 5% threshold.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CAZ-AVI | Participants received CAZ-AVI (Zavicefta), 2.5 g (ceftazidime 2g + avibactam 0.5g), IV as 2 hours infusion every 8 hours for a minimum of 7 days and a maximum of 14 days. Participants were followed up to maximum of 32 days after the last dose of study intervention. | 17 | 235 | 35 | 235 | 43 | 235 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac arrest | Cardiac disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Cardio-respiratory arrest | Cardiac disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Cardiogenic shock | Cardiac disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Ileus | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Death | General disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Effusion | General disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Multiple organ dysfunction syndrome | General disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Sudden cardiac death | General disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Hepatic function abnormal | Hepatobiliary disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Liver injury | Hepatobiliary disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Anti-neutrophil cytoplasmic antibody positive vasculitis | Immune system disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Fungaemia | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
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| Intracranial infection | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
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| Pneumonia aspiration | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
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| Pneumonia fungal | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
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| Puncture site infection | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
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| Septic shock | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
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| Brain herniation | Injury, poisoning and procedural complications | MedDRA v26.0 | Non-systematic Assessment |
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| Wound haemorrhage | Injury, poisoning and procedural complications | MedDRA v26.0 | Non-systematic Assessment |
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| Cerebral haemorrhage | Nervous system disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Hypoxic-ischaemic encephalopathy | Nervous system disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Subdural effusion | Nervous system disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Asphyxia | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Hepatic function abnormal | Hepatobiliary disorders | MedDRA v26.0 | Non-systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquires@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 22, 2023 | Apr 12, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000077299 | Healthcare-Associated Pneumonia |
| ID | Term |
|---|---|
| D003428 | Cross Infection |
| D007239 | Infections |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000595613 | avibactam, ceftazidime drug combination |
Not provided
Not provided
Not provided
| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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Participants with HAP received CAZ-AVI, 2.5 g, IV as 2 hours infusion every 8 hours for a maximum of 14 days.
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| Participants |
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