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: November 2023
• 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. -

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
United States	Zai Lab Site 2023	Fairfax	Virginia
United States	Zai Lab Site 2016	Lynwood	California
United States	Zai Lab Site 2025	New York	New York
United States	Zai Lab Site 2022	Tacoma	Washington

Sponsors (1)

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

Country where clinical trial is conducted

United States, 

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