Status: Recruiting
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
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 or VABP with CRABC infections that are resistant to or have failed colistin/polymyxin B treatment.
Participants needed: 248
Trial details
Phase: Phase 3Age: 18-82Biological sex: AllType: InterventionalSponsor: BioVersys SASUpdated: May 4, 2026Locations: 1
Eligibility criteria
Provide written informed consent prior to any study related procedures not part... [+7]
For Part A only, patients with an infection known to be resistant to colistin, w... [+33]