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 (public)

Zai Lab

Status and phase: Enrolling; Phase 3

Conditions: Community-acquired Bacterial Pneumonia

Treatments: Drug: Moxifloxacin; Drug: Omadacycline

Study type: Interventional

Funder types: Industry

Identifiers

NCT06162286

ZL-2401-004

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

100 participants in 2 patient groups

Moxifloxacin

Active Comparator group

Description:

Moxifloxacin IV/PO

Treatment:

Drug: Moxifloxacin

Omadacycline

Experimental group

Description:

Omadacycline IV/PO

Treatment:

Drug: Omadacycline