Clinical trial NCT06162286: 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
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Community-acquired Bacterial Pneumonia
Lead sponsor: Zai Lab (Hong Kong), Ltd.
Sponsor class: INDUSTRY
First posted: 2023-12-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

   -

Primary outcomes:
measure: Overall assessment of clinical response rate at post therapy evaluation (PTE) timepoint in the mITT population.
timeFrame: 18 months
Secondary outcomes:
measure: 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.
timeFrame: 72 to 120 hours
measure: Clinical response rate at the End of Treatment (EOT) assessment in the mITT and CE population.
timeFrame: 18 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tsinghua Chang Gung Hospital/Infectious Diseases Department
city: Beijing
country: China
facility: Peking University Shougang Hospital/Respiratory and Critical Care Medicine Department
city: Bengbu
country: China
facility: The First Affiliated Hospital of Bengbu Medical College/Intensive care unit
city: Changsha
country: China
facility: The Central Hospital of Changsha/Department of Respiratory and Critical Care Medicine
city: Changsha
country: China
facility: The Third Hospital of Changsha/Respiratory and Critical Care Medicine Department
city: Changsha
country: China
facility: Xiangya Hospital Central South University/Department of Respiratory and Critical Care Medicine
city: Chengdu
country: China
facility: West China Hospital of Sichuan University/Infectious Disease Center
city: Foshan
country: China
facility: The First People's Hospital of Foshan/Department of Respiratory and Critical Care Medicine
city: Fuyang
country: China
facility: Fuyang People's Hospital/Department of Respiratory and Critical Care Medicine
city: Gannan
country: China
facility: The First Affiliated Hospital of Gannan Medical University/Pneumology Department
city: Guangzhou
country: China
facility: Guangdong Second Central Hospital/Department of Respiratory and Critical Care Medicine
city: Guangzhou
country: China
facility: Guangzhou First People's Hospital/Respiratory and Critical Care Medicine Department
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University/Respiratory Medicine
city: Hangzhou
country: China
facility: The Hospital of Zhejiang/Respiratory Medicine
city: Jiangyin
country: China
facility: Jiangyin People's Hospital/Department of Respiratory and Critical Care Medicine
city: Jiaxing
country: China
facility: The First Hospital of Jiaxing/Pneumology Department
city: Kunming
country: China
facility: Kunming First People's Hospital/Respiratory Medicine
city: Luoyang
country: China
facility: The Central Hospital of Luoyang/Department of Respiratory and Critical Care Medicine
city: Mianyang
country: China
facility: The Central Hospital of Mianyang/Department of Respiratory and Critical Care Medicine
city: Nanchang
country: China
facility: Jiangxi Province People's Hospital/Pneumology Department
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
city: Nanning
country: China
facility: The First People's Hospital of Nanning/Department of Respiratory and Critical Care Medicine
city: Nanning
country: China
facility: The People's Hospital of Guangxi Zhuang Autonomous Region/Department of Respiratory and Critical Care Medicine
city: Quanzhou
country: China
facility: Quanzhou First Hospital/Infectious Disease Department
city: Shanghai
country: China
facility: Huashan Hospital
city: Shanghai
country: China
facility: Shanghai Fifth People's Hospital,Fudan University/Department of Respiratory and Critical Care Medicine
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital/Respiratory and Critical Care Medicine Department
city: Shenyang
country: China
facility: The Central Hospital of Shenyang/Department of Respiratory and Critical Care Medicine
city: Shenzhen
country: China
facility: Shenzhen People's Hospital/Department of Respiratory and Critical Care Medicine
city: Shijia Zhuang
country: China
facility: Shijiazhuang People's Hospital/Respiratory Medicine
city: Suzhou
country: China
facility: Suzhou Municipal Hospital/Department of Respiratory and Critical Care Medicine
city: Wenzhou
country: China
facility: The 2nd Affiliated Hospital of Wenzhou Medical University/Department of Respiratory and Critical Care Medicine
city: Wenzhou
country: China
facility: Wenzhou Central Hospital/Department of Respiratory and Critical Care Medicine
city: Wuhan
country: China
facility: The Central Hospital of Wuhan/Respiratory and Critical Care Medicine Department
city: Xiamen
country: China
facility: Zhongshan Hospital Xiamen University/Pneumology Department
city: Xinjiang
country: China
facility: The First Affiliated Hospital of Xinjiang Medical University/Pneumology Department
city: Xinxiang
country: China
facility: The Central Hospital of Xinxiang/Department of Respiratory and Critical Care Medicine
city: Yinchuan
country: China
facility: People's Hospital of Ningxia Hui Autonomous Region/Pneumology Department
city: Zhejiang
country: China
facility: Zhejiang Provincial People's Hospital/Respiratory Medicine
city: Zibo
country: China
facility: Zibo Municipal Hospital/Department of Respiratory and Critical Care Medicine
Study officials:
affiliation: Huashan Hospital
name: Haihui Huang, PhD
role: PRINCIPAL_INVESTIGATOR
References: