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
NCT ID: NCT06162286
Last Updated: 2024-06-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
100 participants
INTERVENTIONAL
2023-11-17
2025-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Moxifloxacin
Moxifloxacin IV/PO
Moxifloxacin
Moxifloxacin IV/PO
Omadacycline
Omadacycline IV/PO
Omadacycline
Omadacycline IV/PO
Interventions
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Omadacycline
Omadacycline IV/PO
Moxifloxacin
Moxifloxacin IV/PO
Eligibility Criteria
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Inclusion Criteria
2. Male or female, ages 18 years or older.
3. Has at least 3 of the following symptoms:
* Cough
* Production of purulent sputum
* Dyspnea (shortness of breath)
* Chest pain
4. Has at least 2 of the following abnormal vital signs:
* Fever or hypothermia documented by the investigator (temperature \> 38.0°C or \< 36.0°C)
* Hypotension with systolic blood pressure (SBP) \< 90 mmHg
* Heart rate (HR) \> 90 beats per minute (bpm)
* Respiratory rate (RR) \> 20 breaths/minute
Exclusion Criteria
Subjects may be eligible despite prior antibacterial therapy if they had been treated with short action time antimicrobial for ≤24h, or if they have received \> 48 hours of prior systemic antibacterial therapy for the current episode of CABP with unequivocal clinical evidence of treatment failure.
2. Is known or suspected to have CABP caused by a pathogen that may be resistant to either test article (eg, Klebsiella pneumoniae, Pseudomonas aeruginosa, Pneumocystis jiroveci, obligate anaerobes, mycobacteria, fungal pathogens).
\-
18 Years
ALL
No
Sponsors
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Zai Lab (Hong Kong), Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Haihui Huang, PhD
Role: PRINCIPAL_INVESTIGATOR
Huashan Hospital
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Xuzhu Ma
Role: primary
Pingchao Xiang
Role: primary
Huaxue Wang
Role: primary
Hongzhong Yang
Role: primary
Yingqun Zhu
Role: primary
Yuanyuan Li
Role: primary
Hui Ye
Role: primary
Minjing Li
Role: primary
Bin Liu
Role: primary
Xiaoliang Yuan
Role: primary
Ruilin Sun
Role: primary
Ziwen Zhao
Role: primary
Feng Ye
Role: primary
Jian Ye
Role: primary
Chengying Liu
Role: primary
Xiaodong Lv
Role: primary
Meihua Li
Role: primary
Nali Zhang
Role: primary
Guowei Xu
Role: primary
Zuke Xiao
Role: primary
Fei Xu
Role: primary
Liangming Zhang
Role: primary
Jianfeng Meng
Role: primary
Zhijun Su
Role: primary
Jinfu Xu
Role: primary
Shuyue Xia
Role: primary
Lingwei Wang
Role: primary
Jinying Shi
Role: primary
Bao Lin
Role: primary
Yuanrong Dai
Role: primary
Qiong Chi
Role: primary
Yi Hu
Role: primary
Huiqing Zeng
Role: primary
Bin Jia
Role: primary
Shengxi Ma
Role: primary
Yilan Sun
Role: primary
Lijun Suo
Role: primary
Other Identifiers
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ZL-2401-004
Identifier Type: -
Identifier Source: org_study_id
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