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

ConditionHospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Meropenem and Pralurbactam
Drug
3g，q8h，120min infusion
Ceftazidime-avibactam
Drug
2.5g，q8h，120min infusion

Treatment groups

420 Participants

are divided into 2 treatment groups

Group A: Meropenem and PralurbactamExperimental treatment 1 intervention

Group B: Ceftazidime-avibactamActive comparator 1 intervention

Trial outcomes

Primary outcomes

Proportion of Participants Who Died Due to Any Cause Description: Due to Day 14，Proportion of Participants Who Died Due to Any Cause in mITT

Time frame

Day 14

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Qilu Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

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