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RECRUITINGPHASE3

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)

NCT06162286•Zai Lab (Hong Kong), Ltd.

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Written and signed informed consent obtained before any protocol specific assessment is performed.
•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
+2 more criteria

Exclusion Criteria

•1. 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.
•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).
•\-

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

Key Dates

Start Date

November 17, 2023

Primary Completion Date

January 1, 2025

Completion Date

November 30, 2025

Last Updated

June 14, 2024

Enrollment

100

ESTIMATED participants

Conditions

Community-acquired Bacterial Pneumonia

Interventions

Omadacycline

DRUG

Moxifloxacin

DRUG

Contacts

Harriet Li

CONTACT

6502316519 harriet.li@zailaboratory.com

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TERMINATEDPHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 14, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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