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
- Conditions
- Community-acquired Bacterial Pneumonia
- Interventions
- Registration Number
- NCT06162286
- Lead Sponsor
- Zai Lab (Hong Kong), Ltd.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
-
Written and signed informed consent obtained before any protocol specific assessment is performed.
-
Male or female, ages 18 years or older.
-
Has at least 3 of the following symptoms:
- Cough
- Production of purulent sputum
- Dyspnea (shortness of breath)
- Chest pain
-
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
-
Has received antibacterial treatment >24hr within the 72hr window prior to randomization.
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.
-
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).
-
Suspected or confirmed empyema (a parapneumonic pleural effusion is not an exclusion criteria) or lung abscess.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Moxifloxacin Moxifloxacin Moxifloxacin IV/PO Omadacycline Omadacycline Omadacycline IV/PO
- Primary Outcome Measures
Name Time Method Overall assessment of clinical response rate at post therapy evaluation (PTE) timepoint in the mITT population. 18 months
- Secondary Outcome Measures
Name Time Method Clinical response rate at the End of Treatment (EOT) assessment in the mITT and CE population. 18 months Clinical response rate at the Early Clinical Response (ECR) assessment (72 to 120 hours after administration of the first dose of test article) in the mITT population. 72 to 120 hours
Trial Locations
- Locations (40)
The Third Hospital of Changsha/Respiratory and Critical Care Medicine Department
🇨🇳Changsha, China
Kunming First People's Hospital/Respiratory Medicine
🇨🇳Kunming, China
Shanghai Pulmonary Hospital/Respiratory and Critical Care Medicine Department
🇨🇳Shanghai, 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
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
Quanzhou First Hospital/Infectious Disease Department
🇨🇳Quanzhou, China
Shenzhen People's Hospital/Department of Respiratory and Critical Care Medicine
🇨🇳Shenzhen, China
Shijiazhuang People's Hospital/Respiratory Medicine
🇨🇳Shijia Zhuang, 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
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
Xiangya Hospital Central South University/Department of Respiratory and Critical Care Medicine
🇨🇳Changsha, China
The Central Hospital of Changsha/Department of Respiratory and Critical Care Medicine
🇨🇳Changsha, China
West China Hospital of Sichuan University/Infectious Disease Center
🇨🇳Chengdu, China
Fuyang People's Hospital/Department of Respiratory and Critical Care Medicine
🇨🇳Fuyang, China
Beijing Tsinghua Chang Gung Hospital/Infectious Diseases Department
🇨🇳Beijing, China
The Central Hospital of Shenyang/Department of Respiratory and Critical Care Medicine
🇨🇳Shenyang, China
Huashan Hospital
🇨🇳Shanghai, China
Shanghai Fifth People's Hospital,Fudan University/Department of Respiratory and Critical Care Medicine
🇨🇳Shanghai, China
Zhongshan Hospital Xiamen University/Pneumology Department
🇨🇳Xiamen, China
Suzhou Municipal Hospital/Department of Respiratory and Critical Care Medicine
🇨🇳Suzhou, China
The First Affiliated Hospital of Xinjiang Medical University/Pneumology Department
🇨🇳Xinjiang, China
People's Hospital of Ningxia Hui Autonomous Region/Pneumology Department
🇨🇳Yinchuan, China
The Central Hospital of Xinxiang/Department of Respiratory and Critical Care Medicine
🇨🇳Xinxiang, China
The First People's Hospital of Foshan/Department of Respiratory and Critical Care Medicine
🇨🇳Foshan, 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
Zhejiang Provincial People's Hospital/Respiratory Medicine
🇨🇳Zhejiang, China
Zibo Municipal Hospital/Department of Respiratory and Critical Care Medicine
🇨🇳Zibo, China