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

Community-acquired Bacterial Pneumonia Clinical Trial

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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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06162286
• Other study ID #: ZL-2401-004
• Status: Recruiting
• Phase: Phase 3
• Start date: November 17, 2023
• Est. completion date: November 30, 2025

Study information

• Verified date: June 2024
• Source: Zai Lab (Hong Kong), Ltd.
• Contact: Harriet Li
• Phone: 6502316519
• Email: harriet.li[@]zailaboratory.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 30, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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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Related Conditions & MeSH terms

• Community-acquired Bacterial Pneumonia
• Pneumonia
• Pneumonia, Bacterial

Intervention

Drug:
• Omadacycline
Omadacycline IV/PO
• Moxifloxacin
Moxifloxacin IV/PO

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Zai Lab (Hong Kong), Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall assessment of clinical response rate at post therapy evaluation (PTE) timepoint in the mITT population.		18 months
Secondary	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.		72 to 120 hours
Secondary	Clinical response rate at the End of Treatment (EOT) assessment in the mITT and CE population.		18 months