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
A Phase 3 Prospective, Randomized, Multicenter, Active-controlled Study to Evaluate the Efficacy and Safety of BV100 Plus Low-dose Polymyxin B Compared With Colistin Plus High-dose Ampicillin/Sulbactam in the Treatment of Adult Patients With Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia Caused by Carbapenem-resistant Acinetobacter Baumannii-calcoaceticus Complex
BioVersys SAS
248 participants
Mar 27, 2026
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
300 mg BV100 nfused over 2 hours every 12 hours (q12h).Treatment for 7 days up to 14 days if clinically indicated.
50 mg polymyxin B infused over 2 hours every 12 hours (q12h).Treatment for 7 days up to 14 days if clinically indicated.
Colistin (4,500,000 units infused over 1 hour every 12 hours (q12h), after an initial loading dose of 9,000,000 units infused over 1 hour).Treatment for 7 days up to 14 days if clinically indicated.
High dose ampicillin/sulbactam (6 g/3 g IV over 4 hours q8h).Treatment for 7 days up to 14 days if clinically indicated.
meropenem infused over 1 hour every 8 hours (q8h).Treatment for 7 days up to 14 days if clinically indicated.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07326540