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A Phase 3b Randomized, Double-blind, Multi-center Study to Compare the Safety and Efficacy of Omadacycline to Moxifloxacin for Treating Adult Subjects With CABP
Sponsor: Zai Lab (Hong Kong), Ltd.
Summary
The primary objective of the study is to show that in Chinese adults with CABP, a course of IV/PO treatment with omadacycline has similar clinical efficacy as the with the comparator antibiotic, IV/PO moxifloxacin. The study is designed as a bridging study, to confirm the results of the pivotal global CABP trial in an ethnically different population of Chinese.
Official title: A Phase 3b Randomized, Double-blind, Multi-center Study to Compare the Safety and Efficacy of Omadacycline IV/PO to Moxifloxacin IV/PO for Treating Adult Subjects With Community-acquired Bacterial Pneumonia (CABP)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2023-11-17
Completion Date
2025-11-30
Last Updated
2024-06-14
Healthy Volunteers
No
Conditions
Interventions
Omadacycline
Omadacycline IV/PO
Moxifloxacin
Moxifloxacin IV/PO
Locations (40)
Beijing Tsinghua Chang Gung Hospital/Infectious Diseases Department
Beijing, China
Peking University Shougang Hospital/Respiratory and Critical Care Medicine Department
Beijing, China
The First Affiliated Hospital of Bengbu Medical College/Intensive care unit
Bengbu, China
The Central Hospital of Changsha/Department of Respiratory and Critical Care Medicine
Changsha, China
The Third Hospital of Changsha/Respiratory and Critical Care Medicine Department
Changsha, China
Xiangya Hospital Central South University/Department of Respiratory and Critical Care Medicine
Changsha, China
West China Hospital of Sichuan University/Infectious Disease Center
Chengdu, China
The First People's Hospital of Foshan/Department of Respiratory and Critical Care Medicine
Foshan, China
Fuyang People's Hospital/Department of Respiratory and Critical Care Medicine
Fuyang, China
The First Affiliated Hospital of Gannan Medical University/Pneumology Department
Gannan, China
Guangdong Second Central Hospital/Department of Respiratory and Critical Care Medicine
Guangzhou, China
Guangzhou First People's Hospital/Respiratory and Critical Care Medicine Department
Guangzhou, China
The First Affiliated Hospital of Guangzhou Medical University/Respiratory Medicine
Guangzhou, China
The Hospital of Zhejiang/Respiratory Medicine
Hangzhou, China
Jiangyin People's Hospital/Department of Respiratory and Critical Care Medicine
Jiangyin, China
The First Hospital of Jiaxing/Pneumology Department
Jiaxing, China
Kunming First People's Hospital/Respiratory Medicine
Kunming, China
The Central Hospital of Luoyang/Department of Respiratory and Critical Care Medicine
Luoyang, China
The Central Hospital of Mianyang/Department of Respiratory and Critical Care Medicine
Mianyang, China
Jiangxi Province People's Hospital/Pneumology Department
Nanchang, China
The First Affiliated Hospital of Nanchang University
Nanchang, China
The First People's Hospital of Nanning/Department of Respiratory and Critical Care Medicine
Nanning, China
The People's Hospital of Guangxi Zhuang Autonomous Region/Department of Respiratory and Critical Care Medicine
Nanning, China
Quanzhou First Hospital/Infectious Disease Department
Quanzhou, China
Huashan Hospital
Shanghai, China
Shanghai Fifth People's Hospital,Fudan University/Department of Respiratory and Critical Care Medicine
Shanghai, China
Shanghai Pulmonary Hospital/Respiratory and Critical Care Medicine Department
Shanghai, China
The Central Hospital of Shenyang/Department of Respiratory and Critical Care Medicine
Shenyang, China
Shenzhen People's Hospital/Department of Respiratory and Critical Care Medicine
Shenzhen, China
Shijiazhuang People's Hospital/Respiratory Medicine
Shijia Zhuang, China
Suzhou Municipal Hospital/Department of Respiratory and Critical Care Medicine
Suzhou, China
The 2nd Affiliated Hospital of Wenzhou Medical University/Department of Respiratory and Critical Care Medicine
Wenzhou, China
Wenzhou Central Hospital/Department of Respiratory and Critical Care Medicine
Wenzhou, China
The Central Hospital of Wuhan/Respiratory and Critical Care Medicine Department
Wuhan, China
Zhongshan Hospital Xiamen University/Pneumology Department
Xiamen, China
The First Affiliated Hospital of Xinjiang Medical University/Pneumology Department
Xinjiang, China
The Central Hospital of Xinxiang/Department of Respiratory and Critical Care Medicine
Xinxiang, China
People's Hospital of Ningxia Hui Autonomous Region/Pneumology Department
Yinchuan, China
Zhejiang Provincial People's Hospital/Respiratory Medicine
Zhejiang, China
Zibo Municipal Hospital/Department of Respiratory and Critical Care Medicine
Zibo, China