A Study to Evaluate the Efficacy and Safety of Meropenem and Pralurbactam in HABP/VABP

NCT07327619 | Recruiting Phase 3

• 1 other identifier: FL058-303
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to evaluate the efficacy and safety of Meropenem and Pralurbactam for Injection in Subjects with HABP/VABP. The primary objective is to demonstrate non-inferiority of Meropenem and Pralurbactam to Ceftazidime and Avibactam Sodium for Injection. This study is a randomized, double-blind, active-controlled study. The total duration of the study will be approximately 32 days including screening and follow-up.

Conditions

Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants Who Died Due to Any Cause Description: Due to Day 14，Proportion of Participants Who Died Due to Any Cause in mITT

  Day 14

Study Arms (2)

Meropenem and Pralurbactam

EXPERIMENTAL

Drug: Meropenem and Pralurbactam

Ceftazidime-avibactam

ACTIVE COMPARATOR

Drug: Ceftazidime-avibactam

Interventions

Meropenem and Pralurbactam DRUG

3g，q8h，120min infusion

Meropenem and Pralurbactam

Ceftazidime-avibactam DRUG

2.5g，q8h，120min infusion

Ceftazidime-avibactam

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Male or female participants ≥18 and ≤80 years of age
• \. have a diagnosis of HAP/VAP.
• \. have systemic signs and respiratory signs or symptoms of HAP/VAP.
• \. New or worsening infiltrate on chest X-ray/CT obtained within 48 hours prior to screening.
• \. The estimated survival time is at lest 28 days.

You may not qualify if:

• \. Diagnosed or suspected CAP, Atypical pneumonias, Viral pneumonia or Chemical pneumonia.
• \. The total duration of antibiotic exposure for antibiotics whose administration begins in the 72 hours is longer than 24 hours.
• \. Acute Physiology and Chronic Health Evaluation (APACHE) II score \>30.
• \. Allergic to any carbapenem, cephalosporin, penicillin, metronidazole disodium phosphate, other beta-lactam drugs or other beta-lactamase inhibitors and their auxiliary materials.
• \. Those who have a history of drug abuse or drug abuse within 6 months before screening.
• \. Those who participated in other clinical trials within 28 days before randomization and used any test drugs or medical devices.

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Hunan University Of Medicine General Hospital

Huaihua, Hunan, 418000, China

RECRUITING

MeSH Terms

Interventions

Meropenem; avibactam, ceftazidime drug combination

Intervention Hierarchy (Ancestors)

Thienamycins; Carbapenems; beta-Lactams; Lactams; Amides; Organic Chemicals; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Bin Cao, PhD

CONTACT

010 8420 6266; caobin_ben@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2025
• First Posted: January 8, 2026
• Study Start: January 22, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: February 17, 2026

Record last verified: 2025-09

Locations

CN (1)