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

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Apr 2026 to Jan 22, 2026v2 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Apr 2026 to Jan 22, 2026
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07327619
Lead Sponsor Qilu Pharmaceutical Co., Ltd.
Conditions Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia
Enrollment 420 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov