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A Study to Evaluate the Efficacy and Safety of Meropenem and Pralurbactam in HABP/VABP
Sponsor: Qilu Pharmaceutical Co., Ltd.
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
420
Start Date
2026-01-22
Completion Date
2028-10
Last Updated
2026-02-17
Healthy Volunteers
No
Interventions
Meropenem and Pralurbactam
3g,q8h,120min infusion
Ceftazidime-avibactam
2.5g,q8h,120min infusion
Locations (1)
Hunan University Of Medicine General Hospital
Huaihua, Hunan, China