Actively Recruiting
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
Led by Zai Lab (Hong Kong), Ltd. · Updated on 2024-06-14
100
Participants Needed
40
Research Sites
106 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written and signed informed consent before any study assessments
- Male or female aged 18 years or older
- Has at least 3 of these symptoms: cough, producing purulent sputum, shortness of breath, chest pain
- Has at least 2 abnormal vital signs: fever (>38.0°C) or low temperature (<36.0°C), low systolic blood pressure (<90 mmHg), heart rate >90 bpm, respiratory rate >20 breaths/min
You will not qualify if you...
- Received more than 24 hours of antibacterial treatment within 72 hours before randomization, except short-acting antimicrobials for ≤24 hours or >48 hours of prior therapy with clear evidence of treatment failure
- Known or suspected CABP caused by pathogens possibly resistant to the study drugs, including Klebsiella pneumoniae, Pseudomonas aeruginosa, Pneumocystis jiroveci, obligate anaerobes, mycobacteria, or fungal pathogens
- Suspected or confirmed empyema or lung abscess
AI-Screening
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Trial Site Locations
Total: 40 locations
1
Beijing Tsinghua Chang Gung Hospital/Infectious Diseases Department
Beijing, China
Actively Recruiting
2
Peking University Shougang Hospital/Respiratory and Critical Care Medicine Department
Beijing, China
Actively Recruiting
3
The First Affiliated Hospital of Bengbu Medical College/Intensive care unit
Bengbu, China
Actively Recruiting
4
The Central Hospital of Changsha/Department of Respiratory and Critical Care Medicine
Changsha, China
Actively Recruiting
5
The Third Hospital of Changsha/Respiratory and Critical Care Medicine Department
Changsha, China
Actively Recruiting
6
Xiangya Hospital Central South University/Department of Respiratory and Critical Care Medicine
Changsha, China
Actively Recruiting
7
West China Hospital of Sichuan University/Infectious Disease Center
Chengdu, China
Actively Recruiting
8
The First People's Hospital of Foshan/Department of Respiratory and Critical Care Medicine
Foshan, China
Actively Recruiting
9
Fuyang People's Hospital/Department of Respiratory and Critical Care Medicine
Fuyang, China
Actively Recruiting
10
The First Affiliated Hospital of Gannan Medical University/Pneumology Department
Gannan, China
Actively Recruiting
11
Guangdong Second Central Hospital/Department of Respiratory and Critical Care Medicine
Guangzhou, China
Actively Recruiting
12
Guangzhou First People's Hospital/Respiratory and Critical Care Medicine Department
Guangzhou, China
Actively Recruiting
13
The First Affiliated Hospital of Guangzhou Medical University/Respiratory Medicine
Guangzhou, China
Actively Recruiting
14
The Hospital of Zhejiang/Respiratory Medicine
Hangzhou, China
Actively Recruiting
15
Jiangyin People's Hospital/Department of Respiratory and Critical Care Medicine
Jiangyin, China
Actively Recruiting
16
The First Hospital of Jiaxing/Pneumology Department
Jiaxing, China
Actively Recruiting
17
Kunming First People's Hospital/Respiratory Medicine
Kunming, China
Actively Recruiting
18
The Central Hospital of Luoyang/Department of Respiratory and Critical Care Medicine
Luoyang, China
Actively Recruiting
19
The Central Hospital of Mianyang/Department of Respiratory and Critical Care Medicine
Mianyang, China
Actively Recruiting
20
Jiangxi Province People's Hospital/Pneumology Department
Nanchang, China
Actively Recruiting
21
The First Affiliated Hospital of Nanchang University
Nanchang, China
Actively Recruiting
22
The First People's Hospital of Nanning/Department of Respiratory and Critical Care Medicine
Nanning, China
Actively Recruiting
23
The People's Hospital of Guangxi Zhuang Autonomous Region/Department of Respiratory and Critical Care Medicine
Nanning, China
Actively Recruiting
24
Quanzhou First Hospital/Infectious Disease Department
Quanzhou, China
Actively Recruiting
25
Huashan Hospital
Shanghai, China
Actively Recruiting
26
Shanghai Fifth People's Hospital,Fudan University/Department of Respiratory and Critical Care Medicine
Shanghai, China
Withdrawn
27
Shanghai Pulmonary Hospital/Respiratory and Critical Care Medicine Department
Shanghai, China
Actively Recruiting
28
The Central Hospital of Shenyang/Department of Respiratory and Critical Care Medicine
Shenyang, China
Actively Recruiting
29
Shenzhen People's Hospital/Department of Respiratory and Critical Care Medicine
Shenzhen, China
Actively Recruiting
30
Shijiazhuang People's Hospital/Respiratory Medicine
Shijia Zhuang, China
Actively Recruiting
31
Suzhou Municipal Hospital/Department of Respiratory and Critical Care Medicine
Suzhou, China
Actively Recruiting
32
The 2nd Affiliated Hospital of Wenzhou Medical University/Department of Respiratory and Critical Care Medicine
Wenzhou, China
Actively Recruiting
33
Wenzhou Central Hospital/Department of Respiratory and Critical Care Medicine
Wenzhou, China
Actively Recruiting
34
The Central Hospital of Wuhan/Respiratory and Critical Care Medicine Department
Wuhan, China
Actively Recruiting
35
Zhongshan Hospital Xiamen University/Pneumology Department
Xiamen, China
Actively Recruiting
36
The First Affiliated Hospital of Xinjiang Medical University/Pneumology Department
Xinjiang, China
Actively Recruiting
37
The Central Hospital of Xinxiang/Department of Respiratory and Critical Care Medicine
Xinxiang, China
Actively Recruiting
38
People's Hospital of Ningxia Hui Autonomous Region/Pneumology Department
Yinchuan, China
Withdrawn
39
Zhejiang Provincial People's Hospital/Respiratory Medicine
Zhejiang, China
Actively Recruiting
40
Zibo Municipal Hospital/Department of Respiratory and Critical Care Medicine
Zibo, China
Actively Recruiting
Research Team
H
Harriet Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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