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Clinical trial

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

NCT07326540 is registered in ClinicalTrials.gov with BioVersys SAS as lead sponsor.

NCT NCT07326540
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Registry record

As filed in ClinicalTrials.gov.

Title
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
Lead sponsor
BioVersys SAS
Phase
Phase 3
Overall status
Recruiting
Start date
March 27, 2026
Completion date
March 30, 2028
Enrollment
248 (estimated)
Sites
1

Conditions

As the registry lists them; a condition with its own page is linked.

acinetobacter baumannii-calcoaceticus complex, colistin resistanrt abc, hospital acquired bacterial pneumonia (habp), ventilator associated bacterial pneumonia (vabp)