RecruitingPhase 3NCT06162286

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

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)

Sponsor

Zai Lab (Hong Kong), Ltd.

Enrollment

100 participants

Start Date

Nov 17, 2023

Study Type

INTERVENTIONAL

Conditions

Community-acquired Bacterial Pneumonia

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Moxifloxacin and a drug called Omadacycline for people with community-acquired bacterial pneumonia. The study is currently recruiting participants at 40 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGOmadacycline

Omadacycline IV/PO

DRUGMoxifloxacin

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06162286