A Study to Evaluate the Efficacy and Safety of Meropenem and Pralurbactam in HABP/VABP
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Meropenem and Pralurbactam, Ceftazidime-avibactam.
- Who it may be relevant to
- Registry conditions: Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Drug Meropenem and Pralurbactam
3g，q8h，120min infusion - Drug Ceftazidime-avibactam
2.5g，q8h，120min infusion
Primary outcome measures
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Hunan University Of Medicine General Hospital — Huaihua
Identifiers
NCT: NCT07327619 · FL058-303