Study to Assess the Efficacy and Safety of Meropenem and Pralurbactam in Carbapenem-Resistant Enterobacteriaceae Infections
Recruiting
Phase 3
Interventional Study
Hospital-acquired Bacterial Pneumonia (HABP)
Ventilator-associated Bacterial Pneumonia (VABP)
Complicated Intra-abdominal Infection (cIAI)
Complicated Urinary Tract Infection (cUTI)
Bloodstream Infection (BSI)
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
- 80 (estimated)
- Sponsor
- Qilu Pharmaceutical Co., Ltd. · Industry
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About This Trial
The study will evaluate the efficacy and safety of Meropenem and Pralurbactam versus Best Available Therapy in the treatment of Carbapenem-Resistant Enterobacteriaceae Infections. Infections evaluated in the study will be hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), complicated intra-abdominal infection (cIAI), complicated urinary tract infection …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Hospitalized male or female≥18 and ≤80 years of age，
* Participant must have a diagnosis of an infection (HABP/VABP, cUTI, cIAI, BSI) due to confirmed Carbapenem-Resistant Enterobacteriaceae infection, requiring administration of IV antibacterial therapy
* Participant who had …
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