Efficacy and Safety of Ceftazidime-Avibactam (CAZ-AVI) in Chinese Participants With HAP (Including VAP)
NCT ID: NCT04774094
Last Updated: 2024-09-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
235 participants
INTERVENTIONAL
2021-05-21
2023-05-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CAZ-AVI
Zavicefta, Ceftazidime-Avibactam
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.
Interventions
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Zavicefta, Ceftazidime-Avibactam
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
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
18 Years
90 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Fuyang People's Hospital
Fuyang, Anhui, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Zhongshan Hospital Xiamen University
Xiamen, Fujian, China
Guangzhou First People's Hospital
Guangzhou, Guangdong, China
ZhuJiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, China
Huizhou Central People's Hospital
Huizhou, Guangdong, China
Qingyuan People's Hospital
Qingyuan, Guangdong, China
Shenzhen People's Hospital
Shenzhen, Guangdong, China
The Second People's Hospital of Shenzhen
Shenzhen, Guangdong, China
Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong, China
Central People's Hospital of Zhanjiang
Zhanjiang, Guangdong, China
The First People's Hospital of Nanning
Nanning, Guangxi, China
The Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, China
Hainan General Hospital
Haikou, Hainan, China
Sanya People's Hospital
Sanya, Hainan, China
Affiliated Hospital of Hebei University
Baoding, Hebei, China
Luoyang Central Hospital
Luoyang, Henan, China
NanYang central hospital
Nanyang, Henan, China
NanYang First people's hospital
Nanyang, Henan, China
Henan provincial people's hospital
Zhengzhou, Henan, China
Shiyan Renmin Hospital
Shiyan, Hubei, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
Hunan Provincial People's Hospital
Changsha, Hunan, China
Yueyang People's Hospital
Yueyang, Hunan, China
Baotou Central Hospital
Baotou, Inner Mongolia, China
Baotou Central Hospital
Baotou, Inner Mongolia, China
Huai'an First People's Hospital
Huai'an, Jiangsu, China
Jiangyin People's Hospital
Jiangyin, Jiangsu, China
The First People's Hospital of Lianyungang City
Lianyungang, Jiangsu, China
Taizhou People's Hospital
Taizhou, Jiangsu, China
Affiliated Hospital of Jiangnan University
Wuxi, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Subei People's Hospital of Jiangsu province
Yangzhou, Jiangsu, China
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, China
Affiliated Zhongshan Hospital of Dalian University
Dalian, Liaoning, China
General Hospital of Northern Theater Command
Shenyang, Liaoning, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Chengdu Xinhua Hospital
Chengdu, Sichuan, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
Tianjin Chest Hospital
Tianjin, Tianjin Municipality, China
The First Hospital of Kunming
Kunming, Yunnan, China
Dongyang People's Hospital
Dongyang, Zhejiang, China
Zhejiang Hospital
Hangzhou, Zhejiang, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Zhejiang Hospital
Hangzhou, Zhejiang, China
The 2nd Affiliated Hospital of WMU
Wenzhou, Zhejiang, China
Wenzhou Central Hospital
Wenzhou, Zhejiang, China
Seventh Medical Center, The General Hospital of People's Liberation Army
Beijing, , China
Shanghai Fifth People's Hospital, Fudan University
Shanghai, , China
Zhongshan Hospital Xiamen University
Xiamen, , China
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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C3591026
Identifier Type: -
Identifier Source: org_study_id
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