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

Last updated: June 13, 2024
Sponsor: Zai Lab (Hong Kong), Ltd.
Overall Status: Active - Recruiting

Phase

3

Condition

Pneumonia

Treatment

Moxifloxacin

Omadacycline

Clinical Study ID

NCT06162286
ZL-2401-004
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Written and signed informed consent obtained before any protocol specific assessmentis 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

  1. 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

Exclusion Criteria:

  1. Has received antibacterial treatment >24hr within the 72hr window prior torandomization. Subjects may be eligible despite prior antibacterial therapy if they had beentreated with short action time antimicrobial for ≤24h, or if they have received > 48hours of prior systemic antibacterial therapy for the current episode of CABP withunequivocal clinical evidence of treatment failure.

  2. Is known or suspected to have CABP caused by a pathogen that may be resistant toeither test article (eg, Klebsiella pneumoniae, Pseudomonas aeruginosa, Pneumocystisjiroveci, obligate anaerobes, mycobacteria, fungal pathogens).

  3. Suspected or confirmed empyema (a parapneumonic pleural effusion is not an exclusioncriteria) or lung abscess.

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Moxifloxacin
Phase: 3
Study Start date:
November 17, 2023
Estimated Completion Date:
November 30, 2025

Connect with a study center

  • Beijing Tsinghua Chang Gung Hospital/Infectious Diseases Department

    Beijing,
    China

    Active - Recruiting

  • Peking University Shougang Hospital/Respiratory and Critical Care Medicine Department

    Beijing,
    China

    Active - Recruiting

  • The First Affiliated Hospital of Bengbu Medical College/Intensive care unit

    Bengbu,
    China

    Active - Recruiting

  • The Central Hospital of Changsha/Department of Respiratory and Critical Care Medicine

    Changsha,
    China

    Active - Recruiting

  • The Third Hospital of Changsha/Respiratory and Critical Care Medicine Department

    Changsha,
    China

    Active - Recruiting

  • Xiangya Hospital Central South University/Department of Respiratory and Critical Care Medicine

    Changsha,
    China

    Active - Recruiting

  • West China Hospital of Sichuan University/Infectious Disease Center

    Chengdu,
    China

    Active - Recruiting

  • The First People's Hospital of Foshan/Department of Respiratory and Critical Care Medicine

    Foshan,
    China

    Active - Recruiting

  • Fuyang People's Hospital/Department of Respiratory and Critical Care Medicine

    Fuyang,
    China

    Active - Recruiting

  • The First Affiliated Hospital of Gannan Medical University/Pneumology Department

    Gannan,
    China

    Active - Recruiting

  • Guangdong Second Central Hospital/Department of Respiratory and Critical Care Medicine

    Guangzhou,
    China

    Active - Recruiting

  • Guangzhou First People's Hospital/Respiratory and Critical Care Medicine Department

    Guangzhou,
    China

    Active - Recruiting

  • The First Affiliated Hospital of Guangzhou Medical University/Respiratory Medicine

    Guangzhou,
    China

    Active - Recruiting

  • The Hospital of Zhejiang/Respiratory Medicine

    Hangzhou,
    China

    Active - Recruiting

  • Jiangyin People's Hospital/Department of Respiratory and Critical Care Medicine

    Jiangyin,
    China

    Active - Recruiting

  • The First Hospital of Jiaxing/Pneumology Department

    Jiaxing,
    China

    Active - Recruiting

  • Kunming First People's Hospital/Respiratory Medicine

    Kunming,
    China

    Active - Recruiting

  • The Central Hospital of Luoyang/Department of Respiratory and Critical Care Medicine

    Luoyang,
    China

    Active - Recruiting

  • The Central Hospital of Mianyang/Department of Respiratory and Critical Care Medicine

    Mianyang,
    China

    Active - Recruiting

  • Jiangxi Province People's Hospital/Pneumology Department

    Nanchang,
    China

    Active - Recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang,
    China

    Active - Recruiting

  • The First People's Hospital of Nanning/Department of Respiratory and Critical Care Medicine

    Nanning,
    China

    Active - Recruiting

  • The People's Hospital of Guangxi Zhuang Autonomous Region/Department of Respiratory and Critical Care Medicine

    Nanning,
    China

    Active - Recruiting

  • Quanzhou First Hospital/Infectious Disease Department

    Quanzhou,
    China

    Active - Recruiting

  • Huashan Hospital

    Shanghai,
    China

    Active - Recruiting

  • Shanghai Fifth People's Hospital,Fudan University/Department of Respiratory and Critical Care Medicine

    Shanghai,
    China

    Site Not Available

  • Shanghai Pulmonary Hospital/Respiratory and Critical Care Medicine Department

    Shanghai,
    China

    Active - Recruiting

  • The Central Hospital of Shenyang/Department of Respiratory and Critical Care Medicine

    Shenyang,
    China

    Active - Recruiting

  • Shenzhen People's Hospital/Department of Respiratory and Critical Care Medicine

    Shenzhen,
    China

    Active - Recruiting

  • Shijiazhuang People's Hospital/Respiratory Medicine

    Shijia Zhuang,
    China

    Active - Recruiting

  • Suzhou Municipal Hospital/Department of Respiratory and Critical Care Medicine

    Suzhou,
    China

    Active - Recruiting

  • The 2nd Affiliated Hospital of Wenzhou Medical University/Department of Respiratory and Critical Care Medicine

    Wenzhou,
    China

    Active - Recruiting

  • Wenzhou Central Hospital/Department of Respiratory and Critical Care Medicine

    Wenzhou,
    China

    Active - Recruiting

  • The Central Hospital of Wuhan/Respiratory and Critical Care Medicine Department

    Wuhan,
    China

    Active - Recruiting

  • Zhongshan Hospital Xiamen University/Pneumology Department

    Xiamen,
    China

    Active - Recruiting

  • The First Affiliated Hospital of Xinjiang Medical University/Pneumology Department

    Xinjiang,
    China

    Active - Recruiting

  • The Central Hospital of Xinxiang/Department of Respiratory and Critical Care Medicine

    Xinxiang,
    China

    Active - Recruiting

  • People's Hospital of Ningxia Hui Autonomous Region/Pneumology Department

    Yinchuan,
    China

    Site Not Available

  • Zhejiang Provincial People's Hospital/Respiratory Medicine

    Zhejiang,
    China

    Active - Recruiting

  • Zibo Municipal Hospital/Department of Respiratory and Critical Care Medicine

    Zibo,
    China

    Active - Recruiting

  • Zai Lab Site 2016

    Lynwood, California 90262
    United States

    Site Not Available

  • Zai Lab Site 2025

    New York, New York 10016
    United States

    Site Not Available

  • Zai Lab Site 2023

    Fairfax, Virginia 22031
    United States

    Site Not Available

  • Zai Lab Site 2022

    Tacoma, Washington 98405
    United States

    Site Not Available

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