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)

June 13, 2024 updated by: Zai Lab (Hong Kong), Ltd.

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Beijing Tsinghua Chang Gung Hospital/Infectious Diseases Department
        • Contact:
          • Xuzhu Ma
      • Beijing, China
        • Recruiting
        • Peking University Shougang Hospital/Respiratory and Critical Care Medicine Department
        • Contact:
          • Pingchao Xiang
      • Bengbu, China
        • Recruiting
        • The First Affiliated Hospital of Bengbu Medical College/Intensive care unit
        • Contact:
          • Huaxue Wang
      • Changsha, China
        • Recruiting
        • The Central Hospital of Changsha/Department of Respiratory and Critical Care Medicine
        • Contact:
          • Hongzhong Yang
      • Changsha, China
        • Recruiting
        • The Third Hospital of Changsha/Respiratory and Critical Care Medicine Department
        • Contact:
          • Yingqun Zhu
      • Changsha, China
        • Recruiting
        • Xiangya Hospital Central South University/Department of Respiratory and Critical Care Medicine
        • Contact:
          • Yuanyuan Li
      • Chengdu, China
        • Recruiting
        • West China Hospital of Sichuan University/Infectious Disease Center
        • Contact:
          • Hui Ye
      • Foshan, China
        • Recruiting
        • The First People's Hospital of Foshan/Department of Respiratory and Critical Care Medicine
        • Contact:
          • Minjing Li
      • Fuyang, China
        • Recruiting
        • Fuyang People's Hospital/Department of Respiratory and Critical Care Medicine
        • Contact:
          • Bin Liu
      • Gannan, China
        • Recruiting
        • The First Affiliated Hospital of Gannan Medical University/Pneumology Department
        • Contact:
          • Xiaoliang Yuan
      • Guangzhou, China
        • Recruiting
        • Guangdong Second Central Hospital/Department of Respiratory and Critical Care Medicine
        • Contact:
          • Ruilin Sun
      • Guangzhou, China
        • Recruiting
        • Guangzhou First People's Hospital/Respiratory and Critical Care Medicine Department
        • Contact:
          • Ziwen Zhao
      • Guangzhou, China
        • Recruiting
        • The First Affiliated Hospital of Guangzhou Medical University/Respiratory Medicine
        • Contact:
          • Feng Ye
      • Hangzhou, China
        • Recruiting
        • The Hospital of Zhejiang/Respiratory Medicine
        • Contact:
          • Jian Ye
      • Jiangyin, China
        • Recruiting
        • Jiangyin People's Hospital/Department of Respiratory and Critical Care Medicine
        • Contact:
          • Chengying Liu
      • Jiaxing, China
        • Recruiting
        • The First Hospital of Jiaxing/Pneumology Department
        • Contact:
          • Xiaodong Lv
      • Kunming, China
        • Recruiting
        • Kunming First People's Hospital/Respiratory Medicine
        • Contact:
          • Meihua Li
      • Luoyang, China
        • Recruiting
        • The Central Hospital of Luoyang/Department of Respiratory and Critical Care Medicine
        • Contact:
          • Nali Zhang
      • Mianyang, China
        • Recruiting
        • The Central Hospital of Mianyang/Department of Respiratory and Critical Care Medicine
        • Contact:
          • Guowei Xu
      • Nanchang, China
        • Recruiting
        • The First Affiliated Hospital of NanChang University
        • Contact:
          • Fei Xu
      • Nanchang, China
        • Recruiting
        • Jiangxi Province People's Hospital/Pneumology Department
        • Contact:
          • Zuke Xiao
      • Nanning, China
        • Recruiting
        • The First People's Hospital of Nanning/Department of Respiratory and Critical Care Medicine
        • Contact:
          • Liangming Zhang
      • Nanning, China
        • Recruiting
        • The People's Hospital of Guangxi Zhuang Autonomous Region/Department of Respiratory and Critical Care Medicine
        • Contact:
          • Jianfeng Meng
      • Quanzhou, China
        • Recruiting
        • Quanzhou First Hospital/Infectious Disease Department
        • Contact:
          • Zhijun Su
      • Shanghai, China
        • Recruiting
        • Huashan Hospital
      • Shanghai, China
        • Withdrawn
        • Shanghai Fifth People's Hospital,Fudan University/Department of Respiratory and Critical Care Medicine
      • Shanghai, China
        • Recruiting
        • Shanghai Pulmonary Hospital/Respiratory and Critical Care Medicine Department
        • Contact:
          • Jinfu Xu
      • Shenyang, China
        • Recruiting
        • The Central Hospital of Shenyang/Department of Respiratory and Critical Care Medicine
        • Contact:
          • Shuyue Xia
      • Shenzhen, China
        • Recruiting
        • Shenzhen People's Hospital/Department of Respiratory and Critical Care Medicine
        • Contact:
          • Lingwei Wang
      • Shijia Zhuang, China
        • Recruiting
        • Shijiazhuang People's Hospital/Respiratory Medicine
        • Contact:
          • Jinying Shi
      • Suzhou, China
        • Recruiting
        • Suzhou Municipal Hospital/Department of Respiratory and Critical Care Medicine
        • Contact:
          • Bao Lin
      • Wenzhou, China
        • Recruiting
        • The 2nd Affiliated Hospital of Wenzhou Medical University/Department of Respiratory and Critical Care Medicine
        • Contact:
          • Yuanrong Dai
      • Wenzhou, China
        • Recruiting
        • Wenzhou Central Hospital/Department of Respiratory and Critical Care Medicine
        • Contact:
          • Qiong Chi
      • Wuhan, China
        • Recruiting
        • The Central Hospital of Wuhan/Respiratory and Critical Care Medicine Department
        • Contact:
          • Yi Hu
      • Xiamen, China
        • Recruiting
        • Zhongshan Hospital Xiamen University/Pneumology Department
        • Contact:
          • Huiqing Zeng
      • Xinjiang, China
        • Recruiting
        • The First Affiliated Hospital of Xinjiang Medical University/Pneumology Department
        • Contact:
          • Bin Jia
      • Xinxiang, China
        • Recruiting
        • The Central Hospital of Xinxiang/Department of Respiratory and Critical Care Medicine
        • Contact:
          • Shengxi Ma
      • Yinchuan, China
        • Withdrawn
        • People's Hospital of Ningxia Hui Autonomous Region/Pneumology Department
      • Zhejiang, China
        • Recruiting
        • Zhejiang Provincial People's Hospital/Respiratory Medicine
        • Contact:
          • Yilan Sun
      • Zibo, China
        • Recruiting
        • Zibo Municipal Hospital/Department of Respiratory and Critical Care Medicine
        • Contact:
          • Lijun Suo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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
    • Heart rate (HR) > 90 beats per minute (bpm)
    • Respiratory rate (RR) > 20 breaths/minute

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).

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

    -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Moxifloxacin
Moxifloxacin IV/PO
Drug: Moxifloxacin
Moxifloxacin IV/PO
Experimental: Omadacycline
Omadacycline IV/PO
Drug: Omadacycline
Omadacycline IV/PO

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall assessment of clinical response rate at post therapy evaluation (PTE) timepoint in the mITT population.
Time Frame: 18 months
18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: 72 to 120 hours
72 to 120 hours
Clinical response rate at the End of Treatment (EOT) assessment in the mITT and CE population.
Time Frame: 18 months
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zai Lab (Hong Kong), Ltd.

Investigators

  • Principal Investigator: Haihui Huang, PhD, Huashan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 17, 2023

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

November 30, 2025

Study Registration Dates

First Submitted

November 30, 2023

First Submitted That Met QC Criteria

December 7, 2023

First Posted (Actual)

December 8, 2023

Study Record Updates

Last Update Posted (Actual)

June 14, 2024

Last Update Submitted That Met QC Criteria

June 13, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZL-2401-004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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