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)

Status: Completed
Location: See all (56) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Affiliated Hospital of Hebei University
Baoding
Baotou Central Hospital
Baotou
Baotou Central Hospital
Baotou
Peking University Third Hospital
Beijing
Seventh Medical Center, The General Hospital of People's Liberation Army
Beijing
Hunan Provincial People's Hospital
Changsha
Chengdu Xinhua Hospital
Chengdu
West China Hospital of Sichuan University
Chengdu
Affiliated Zhongshan Hospital of Dalian University
Dalian
Dongyang People's Hospital
Dongyang
Fuyang People's Hospital
Fuyang
The First Affiliated Hospital of Fujian Medical University
Fuzhou
Guangzhou First People's Hospital
Guangzhou
The First Affiliated Hospital of Jinan University
Guangzhou
ZhuJiang Hospital of Southern Medical University
Guangzhou
Hainan General Hospital
Haikou
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Hangzhou
Zhejiang Hospital
Hangzhou
Zhejiang Hospital
Hangzhou
Zhejiang Provincial People's Hospital
Hangzhou
Huai'an First People's Hospital
Huai'an
Huizhou Central People's Hospital
Huizhou
Jiangyin People's Hospital
Jiangyin
The First Hospital of Kunming
Kunming
The First People's Hospital of Lianyungang City
Lianyungang
Luoyang Central Hospital
Luoyang
Jiangxi Provincial People's Hospital
Nanchang
The First People's Hospital of Nanning
Nanning
NanYang central hospital
Nanyang
NanYang First people's hospital
Nanyang
Qingyuan People's Hospital
Qingyuan
Sanya People's Hospital
Sanya
Huashan Hospital Fudan University
Shanghai
Shanghai Fifth People's Hospital, Fudan University
Shanghai
General Hospital of Northern Theater Command
Shenyang
Shenzhen People's Hospital
Shenzhen
The Second People's Hospital of Shenzhen
Shenzhen
Shiyan Renmin Hospital
Shiyan
Taizhou People's Hospital
Taizhou
Tianjin Chest Hospital
Tianjin
Tianjin Medical University General Hospital
Tianjin
The 2nd Affiliated Hospital of WMU
Wenzhou
Wenzhou Central Hospital
Wenzhou
Renmin Hospital of Wuhan University
Wuhan
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan
Affiliated Hospital of Jiangnan University
Wuxi
Zhongshan Hospital Xiamen University
Xiamen
Zhongshan Hospital Xiamen University
Xiamen
The Affiliated Hospital of Xuzhou Medical University
Xuzhou
Subei People's Hospital of Jiangsu province
Yangzhou
General Hospital of Ningxia Medical University
Yinchuan
Yueyang People's Hospital
Yueyang
Affiliated Hospital of Guangdong Medical University
Zhanjiang
Central People's Hospital of Zhanjiang
Zhanjiang
Henan provincial people's hospital
Zhengzhou
The Affiliated Hospital of Zunyi Medical University
Zunyi
Time Frame
Start Date: 2021-05-21
Completion Date: 2023-05-04
Participants
Target number of participants: 235
Treatments
Experimental: CAZ-AVI
Related Therapeutic Areas
Sponsors
Leads: Pfizer

This content was sourced from clinicaltrials.gov