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Community-acquired Bacterial PneumoniaPhase 3publicNCT06162286

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 3 study testing Omadacycline and Moxifloxacin in people with Community-acquired Bacterial Pneumonia, run by Zai Lab (Hong Kong), Ltd. at 40 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Community-acquired Bacterial Pneumonia
What is being tested?
Omadacycline and Moxifloxacin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
40 sitesChina
Study dates
17 Nov 2023to 30 Nov 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written and signed informed consent obtained before any protocol specific assessment is performed.
  • Male or female, ages 18 years or older.
  • Has at least 3 of the following symptoms:
  • Cough
  • Production of purulent sputum
  • Dyspnea (shortness of breath)
Show all 12Show fewer
  • Chest pain
  • 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

Who cannot join

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

Trial locations and contacts

40 sites in 1 country.

Harriet Li contact

6502316519

harriet.li@zailaboratory.com

40 sites in 1 country

China40 sites, 38 recruiting

  • Beijing Tsinghua Chang Gung Hospital/Infectious Diseases Department

    Beijing

    Xuzhu Ma

    Recruiting

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

    Beijing

    Pingchao Xiang

    Recruiting

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

    Bengbu

    Huaxue Wang

    Recruiting

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

    Changsha

    Hongzhong Yang

    Recruiting

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

    Changsha

    Yingqun Zhu

    Recruiting

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

    Changsha

    Yuanyuan Li

    Recruiting

  • West China Hospital of Sichuan University/Infectious Disease Center

    Chengdu

    Hui Ye

    Recruiting

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

    Foshan

    Minjing Li

    Recruiting

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

    Fuyang

    Bin Liu

    Recruiting

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

    Gannan

    Xiaoliang Yuan

    Recruiting

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

    Guangzhou

    Ruilin Sun

    Recruiting

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

    Guangzhou

    Ziwen Zhao

    Recruiting

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

    Guangzhou

    Feng Ye

    Recruiting

  • The Hospital of Zhejiang/Respiratory Medicine

    Hangzhou

    Jian Ye

    Recruiting

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

    Jiangyin

    Chengying Liu

    Recruiting

  • The First Hospital of Jiaxing/Pneumology Department

    Jiaxing

    Xiaodong Lv

    Recruiting

  • Kunming First People's Hospital/Respiratory Medicine

    Kunming

    Meihua Li

    Recruiting

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

    Luoyang

    Nali Zhang

    Recruiting

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

    Mianyang

    Guowei Xu

    Recruiting

  • Jiangxi Province People's Hospital/Pneumology Department

    Nanchang

    Zuke Xiao

    Recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang

    Fei Xu

    Recruiting

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

    Nanning

    Liangming Zhang

    Recruiting

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

    Nanning

    Jianfeng Meng

    Recruiting

  • Quanzhou First Hospital/Infectious Disease Department

    Quanzhou

    Zhijun Su

    Recruiting

  • Huashan Hospital

    Shanghai

    Recruiting

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

    Shanghai

    Withdrawn

  • Shanghai Pulmonary Hospital/Respiratory and Critical Care Medicine Department

    Shanghai

    Jinfu Xu

    Recruiting

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

    Shenyang

    Shuyue Xia

    Recruiting

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

    Shenzhen

    Lingwei Wang

    Recruiting

  • Shijiazhuang People's Hospital/Respiratory Medicine

    Shijia Zhuang

    Jinying Shi

    Recruiting

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

    Suzhou

    Bao Lin

    Recruiting

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

    Wenzhou

    Yuanrong Dai

    Recruiting

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

    Wenzhou

    Qiong Chi

    Recruiting

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

    Wuhan

    Yi Hu

    Recruiting

  • Zhongshan Hospital Xiamen University/Pneumology Department

    Xiamen

    Huiqing Zeng

    Recruiting

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

    Xinjiang

    Bin Jia

    Recruiting

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

    Xinxiang

    Shengxi Ma

    Recruiting

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

    Yinchuan

    Withdrawn

  • Zhejiang Provincial People's Hospital/Respiratory Medicine

    Zhejiang

    Yilan Sun

    Recruiting

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

    Zibo

    Lijun Suo

    Recruiting

Other trials in China

About this study

Official title: 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.

Being tested
Omadacycline, Moxifloxacin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OmadacyclineDrug

    Omadacycline IV/PO

  • MoxifloxacinDrug

    Moxifloxacin IV/PO

Study groups in NCT06162286
Study groupRoleWhat they receive
MoxifloxacinActive comparatorMoxifloxacin IV/PO
Receives: Drug: Moxifloxacin
OmadacyclineExperimentalOmadacycline IV/PO
Receives: Drug: Omadacycline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall assessment of clinical response rate at post therapy evaluation (PTE) timepoint in the mITT population.

    Measured: 18 months

Secondary outcomes (2)

  1. 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.

    Measured: 72 to 120 hours

  2. Clinical response rate at the End of Treatment (EOT) assessment in the mITT and CE population.

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2023
  2. Study start17 Nov 2023
  3. Primary completion1 Jan 2025 (estimated)
  4. Study completion30 Nov 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06162286
Sponsor's protocol ID
ZL-2401-004
Acronym
public
Status last verified
Jun 2024
First submitted
30 Nov 2023
Last updated
14 Jun 2024
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Omadacycline and Moxifloxacin in people with Community-acquired Bacterial Pneumonia, run by Zai Lab (Hong Kong), Ltd. at 40 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Harriet Li (6502316519, harriet.li@zailaboratory.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall assessment of clinical response rate at post therapy evaluation (PTE) timepoint in the mITT population. (time frame: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06162286.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2024.

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