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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

420 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-22

Study Completion Date

2028-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Meropenem and Pralurbactam

Group Type EXPERIMENTAL

Meropenem and Pralurbactam

Intervention Type DRUG

3g，q8h，120min infusion

Ceftazidime-avibactam

Group Type ACTIVE_COMPARATOR

Ceftazidime-avibactam

Intervention Type DRUG

2.5g，q8h，120min infusion

Interventions

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Meropenem and Pralurbactam

3g，q8h，120min infusion

Intervention Type DRUG

Ceftazidime-avibactam

2.5g，q8h，120min infusion

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 1\. Diagnosed or suspected CAP, Atypical pneumonias, Viral pneumonia or Chemical pneumonia.

2\. The total duration of antibiotic exposure for antibiotics whose administration begins in the 72 hours is longer than 24 hours.

3\. Acute Physiology and Chronic Health Evaluation (APACHE) II score \>30.

4\. Allergic to any carbapenem, cephalosporin, penicillin, metronidazole disodium phosphate, other beta-lactam drugs or other beta-lactamase inhibitors and their auxiliary materials.

5\. Those who have a history of drug abuse or drug abuse within 6 months before screening.

6\. Those who participated in other clinical trials within 28 days before randomization and used any test drugs or medical devices.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No