Efficacy and Safety of BV100 Plus Low Dose Polymyxin B Versus Colistin Plus High-dose Ampicillin/Sulbactam in Patients With Hospital-acquired or Ventilator-associated Bacterial Pneumonia Due to Carbapenem-resistant Acinetobacter Baumannii-calcoaceticus Complex

Recruiting Phase 3 Interventional Study
Hospital Acquired Bacterial Pneumonia (HABP) Ventilator Associated Bacterial Pneumonia (VABP) Colistin Resistanrt ABC Acinetobacter Baumannii-calcoaceticus Complex
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.
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At a Glance
Age
18 – 82
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
248 (estimated)
Sponsor
BioVersys SAS · Industry
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About This Trial
This is a two-part study, with Part A being the randomized, controlled portion of the study in patients with hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP) suspected or confirmed to be due to carbapenem-resistant Acinetobacter baumannii-calcoaceticus complex (CRABC). Part B is the single-group portion of the study and includes patients with HABP o…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Provide written informed consent prior to any study related procedures not part of normal medical care. If permitted by local country and institution-specific guidelines, surrogate consent/use of a legally authorized representative may be provided. Alternatively, the decision…
Contacts

Glenn Dale

+41 61 633 22 50

info@bioversys.com

CONTACT