A Multicenter, Randomized, Double-blind, Active-Controlled, Parallel, Phase Ⅲ Study to Evaluate the Efficacy and Safety of Meropenem and Pralurbactam for Injection Compared to Ceftazidime and Avibactam Sodium for Injection in Subjects With Hospital-acquired and Ventilator-associated Bacterial Pneumonia
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• 1\. Male or female participants ≥18 and ≤80 years of age
• 2\. have a diagnosis of HAP/VAP.
• 3\. have systemic signs and respiratory signs or symptoms of HAP/VAP.
• 4\. New or worsening infiltrate on chest X-ray/CT obtained within 48 hours prior to screening.
• 5\. The estimated survival time is at lest 28 days.
Locations
Other Locations
China
Hunan University Of Medicine General Hospital
RECRUITING
Huaihua
Contact Information
Primary
Bin Cao, PhD
caobin_ben@163.com
010 8420 6266
Time Frame
Start Date: 2026-01-22
Estimated Completion Date: 2028-10
Participants
Target number of participants: 420
Treatments
Experimental: Meropenem and Pralurbactam
Active_comparator: Ceftazidime-avibactam
Related Therapeutic Areas
Sponsors
Leads: Qilu Pharmaceutical Co., Ltd.