Efficacy and Safety of Ceftazidime-Avibactam (CAZ-AVI) in Chinese Participants With HAP (Including VAP)
A SINGLE ARM, OPEN-LABEL, MULTI-CENTER, INTERVENTIONAL STUDY EVALUATING THE EFFICACY AND SAFETY OF CEFTAZIDIME-AVIBACTAM (CAZ-AVI) IN CHINESE ADULTS WITH HAP (INCLUDING VAP)
1 other identifier
interventional
235
1 country
56
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2021
56 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 5, 2021
CompletedFirst Posted
Study publicly available on registry
March 1, 2021
CompletedStudy Start
First participant enrolled
May 21, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 4, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 4, 2023
CompletedResults Posted
Study results publicly available
September 19, 2024
CompletedSeptember 19, 2024
April 1, 2024
2 years
February 5, 2021
April 12, 2024
April 12, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (11)
Percentage of Participants With Clinical Cure at EOT Visit: cMITT Population
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
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
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
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
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
- +6 more secondary outcomes
Study Arms (1)
CAZ-AVI
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- Male or female participants ≥18 and ≤90 years of age.
- Onset of symptoms ≥48 hours after admission or \<7 days after discharge from an inpatient acute or chronic care facility.
- New or worsening infiltrate on chest X-ray obtained within 48 hours prior to screening.
- Participants have systemic signs and respiratory signs or symptoms of HAP/VAP
You may not qualify if:
- Other medical or psychiatric condition may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- Participant is expected to require a treatment course for HAP longer than 14 days.
- The total duration of antibiotic exposure for antibiotics whose administration begins in the 48 hours is longer than 24 hours.
- Previous administration with an investigational drug within 30 days or 5 half lives preceding the first dose of study intervention used in this study (whichever is longer).
- Acute Physiology and Chronic Health Evaluation (APACHE) II score \>30 or \<10 using the most recent available data.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (56)
Fuyang People's Hospital
Fuyang, Anhui, 236000, China
Peking University Third Hospital
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
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 5, 2021
First Posted
March 1, 2021
Study Start
May 21, 2021
Primary Completion
May 4, 2023
Study Completion
May 4, 2023
Last Updated
September 19, 2024
Results First Posted
September 19, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will share
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.