Phase 3 Study Comparing Meropenem and Pralurbactam to Ceftazidime and Avibactam for Treating Hospital-acquired and Ventilator-associated Bacterial Pneumonia

What this Trial Is About

This clinical trial is studying adults aged 18 to 80 years who have hospital-acquired bacterial pneumonia HABP or ventilator-associated bacterial pneumonia VABP. Researchers aim to compare the effectiveness and safety of two antibiotic treatments to see if Meropenem and Pralurbactam are not worse than Ceftazidime and Avibactam. This is a phase 3, randomized, double-blind, active-controlled study sponsored by Qilu Pharmaceutical Co., Ltd., lasting about 32 days including screening and follow-up. Participants will receive one of two treatments Meropenem and Pralurbactam given as a 3-gram dose every 8 hours with a 120-minute infusion, or Ceftazidime and Avibactam given as a 2.5-gram dose every 8 hours with a 120-minute infusion. The treatment period and follow-up are included within the total study duration. The study uses a quadruple masking method, meaning participants, care providers, investigators, and outcomes assessors do not know which treatment is given. During the study, participants will be monitored for safety and efficacy, including observing the number of participants who die from any cause up to day 14. Screening includes chest X-rays or CT scans to confirm pneumonia signs. The study assesses systemic and respiratory symptoms and tracks survival for at least 28 days. Participants will be followed through visits during the study to record outcomes and ensure adherence to treatment protocols.

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