A Study to Evaluate the Efficacy and Safety of Meropenem and Pralurbactam in HABP/VABP
Recruiting
Phase 3
Interventional Study
Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 80
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 420 (estimated)
- Sponsor
- Qilu Pharmaceutical Co., Ltd. · Industry
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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 sc…
Trial Locations
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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 es…
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