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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zai Lab (Hong Kong), Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 17, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 30, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 8, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 14, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 13, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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