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
public
1 other identifier
interventional
100
1 country
40
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Nov 2023
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 17, 2023
CompletedFirst Submitted
Initial submission to the registry
November 30, 2023
CompletedFirst Posted
Study publicly available on registry
December 8, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2025
CompletedJune 14, 2024
June 1, 2024
1.1 years
November 30, 2023
June 13, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Overall assessment of clinical response rate at post therapy evaluation (PTE) timepoint in the mITT population.
18 months
Secondary Outcomes (2)
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
Clinical response rate at the End of Treatment (EOT) assessment in the mITT and CE population.
18 months
Study Arms (2)
Moxifloxacin
ACTIVE COMPARATORMoxifloxacin IV/PO
Omadacycline
EXPERIMENTALOmadacycline IV/PO
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Haihui Huang, PhD
Huashan Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 30, 2023
First Posted
December 8, 2023
Study Start
November 17, 2023
Primary Completion
January 1, 2025
Study Completion
November 30, 2025
Last Updated
June 14, 2024
Record last verified: 2024-06