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.

NCT Number	NCT07326540
Lead Sponsor	BioVersys SAS Collaborators: BioVersys AG
Conditions	Hospital Acquired Bacterial Pneumonia (HABP), Ventilator Associated Bacterial Pneumonia (VABP), Colistin Resistanrt ABC, Acinetobacter Baumannii-calcoaceticus Complex
Enrollment	248 participants
Start Date	2026-03-27
Primary Completion	2027-12-30 (estimated)
Study Completion	2028-03-30 (estimated)
Updated on ClinicalTrials.gov	2026-05-04