A Study to Evaluate the Efficacy and Safety of Meropenem and Pralurbactam in HABP/VABP
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorQilu Pharmaceutical Co., Ltd.
About this trial
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 criteria
Qualifiers
1. Male or female participants ≥18 and ≤80 years of age
Disqualifiers
1. Diagnosed or suspected CAP, Atypical pneumonias, Viral pneumonia or Chemical pneumonia.
Trial design
Treatments tested in this trial
- Meropenem and Pralurbactam
- Ceftazidime-avibactam
Treatment groups
420 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov