Comparing omadacycline and moxifloxacin for treating pneumonia in adults

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)

This study is testing whether a new antibiotic called omadacycline works better than moxifloxacin for treating pneumonia in adults in China.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Zai Lab (Hong Kong), Ltd. (industry)
• Locations: 40 sites (Beijing and 39 other locations)
• Trial ID: NCT06162286 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the safety and efficacy of omadacycline compared to moxifloxacin in treating community-acquired bacterial pneumonia (CABP) in Chinese adults. It is a Phase 3b randomized, double-blind, multi-center study designed to confirm the results of a previous global trial in a different ethnic population. Participants will receive either omadacycline or moxifloxacin through intravenous or oral administration, and their clinical outcomes will be monitored. The study focuses on patients exhibiting specific symptoms and vital sign abnormalities associated with CABP.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 years or older who exhibit symptoms and vital sign abnormalities indicative of community-acquired bacterial pneumonia.

Not a fit: Patients who have received antibacterial treatment within 24 hours prior to randomization may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide an effective alternative treatment for CABP, potentially improving patient outcomes.

How similar studies have performed: Previous studies have shown success with similar antibiotic comparisons, but this study aims to confirm findings in a specific ethnic population, making it a novel approach.

Eligibility criteria

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.

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Where this trial is running

Beijing and 39 other locations

• Beijing Tsinghua Chang Gung Hospital/Infectious Diseases Department — Beijing, China (RECRUITING)
• Peking University Shougang Hospital/Respiratory and Critical Care Medicine Department — Beijing, China (RECRUITING)
• The First Affiliated Hospital of Bengbu Medical College/Intensive care unit — Bengbu, China (RECRUITING)
• The Central Hospital of Changsha/Department of Respiratory and Critical Care Medicine — Changsha, China (RECRUITING)
• The Third Hospital of Changsha/Respiratory and Critical Care Medicine Department — Changsha, China (RECRUITING)
• Xiangya Hospital Central South University/Department of Respiratory and Critical Care Medicine — Changsha, China (RECRUITING)
• West China Hospital of Sichuan University/Infectious Disease Center — Chengdu, China (RECRUITING)
• The First People's Hospital of Foshan/Department of Respiratory and Critical Care Medicine — Foshan, China (RECRUITING)
• Fuyang People's Hospital/Department of Respiratory and Critical Care Medicine — Fuyang, China (RECRUITING)
• The First Affiliated Hospital of Gannan Medical University/Pneumology Department — Gannan, China (RECRUITING)
• Guangdong Second Central Hospital/Department of Respiratory and Critical Care Medicine — Guangzhou, China (RECRUITING)
• Guangzhou First People's Hospital/Respiratory and Critical Care Medicine Department — Guangzhou, China (RECRUITING)
• The First Affiliated Hospital of Guangzhou Medical University/Respiratory Medicine — Guangzhou, China (RECRUITING)
• The Hospital of Zhejiang/Respiratory Medicine — Hangzhou, China (RECRUITING)
• Jiangyin People's Hospital/Department of Respiratory and Critical Care Medicine — Jiangyin, China (RECRUITING)
• The First Hospital of Jiaxing/Pneumology Department — Jiaxing, China (RECRUITING)
• Kunming First People's Hospital/Respiratory Medicine — Kunming, China (RECRUITING)
• The Central Hospital of Luoyang/Department of Respiratory and Critical Care Medicine — Luoyang, China (RECRUITING)
• The Central Hospital of Mianyang/Department of Respiratory and Critical Care Medicine — Mianyang, China (RECRUITING)
• Jiangxi Province People's Hospital/Pneumology Department — Nanchang, China (RECRUITING)
• The First Affiliated Hospital of Nanchang University — Nanchang, China (RECRUITING)
• The First People's Hospital of Nanning/Department of Respiratory and Critical Care Medicine — Nanning, China (RECRUITING)
• The People's Hospital of Guangxi Zhuang Autonomous Region/Department of Respiratory and Critical Care Medicine — Nanning, China (RECRUITING)
• Quanzhou First Hospital/Infectious Disease Department — Quanzhou, China (RECRUITING)
• Huashan Hospital — Shanghai, China (RECRUITING)
• Shanghai Fifth People's Hospital,Fudan University/Department of Respiratory and Critical Care Medicine — Shanghai, China (WITHDRAWN)
• Shanghai Pulmonary Hospital/Respiratory and Critical Care Medicine Department — Shanghai, China (RECRUITING)
• The Central Hospital of Shenyang/Department of Respiratory and Critical Care Medicine — Shenyang, China (RECRUITING)
• Shenzhen People's Hospital/Department of Respiratory and Critical Care Medicine — Shenzhen, China (RECRUITING)
• Shijiazhuang People's Hospital/Respiratory Medicine — Shijia Zhuang, China (RECRUITING)
• Suzhou Municipal Hospital/Department of Respiratory and Critical Care Medicine — Suzhou, China (RECRUITING)
• The 2nd Affiliated Hospital of Wenzhou Medical University/Department of Respiratory and Critical Care Medicine — Wenzhou, China (RECRUITING)
• Wenzhou Central Hospital/Department of Respiratory and Critical Care Medicine — Wenzhou, China (RECRUITING)
• The Central Hospital of Wuhan/Respiratory and Critical Care Medicine Department — Wuhan, China (RECRUITING)
• Zhongshan Hospital Xiamen University/Pneumology Department — Xiamen, China (RECRUITING)
• The First Affiliated Hospital of Xinjiang Medical University/Pneumology Department — Xinjiang, China (RECRUITING)
• The Central Hospital of Xinxiang/Department of Respiratory and Critical Care Medicine — Xinxiang, China (RECRUITING)
• People's Hospital of Ningxia Hui Autonomous Region/Pneumology Department — Yinchuan, China (WITHDRAWN)
• Zhejiang Provincial People's Hospital/Respiratory Medicine — Zhejiang, China (RECRUITING)
• Zibo Municipal Hospital/Department of Respiratory and Critical Care Medicine — Zibo, China (RECRUITING)

Study contacts

• Principal investigator: Haihui Huang, PhD — Huashan Hospital
• Study coordinator: Harriet Li

Conditions: Community-acquired Bacterial Pneumonia