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Clinical trial

A Two-part Phase IIb Randomized, Multicenter, Open-label Comparative Study to Firstly Evaluate the Safety and Efficacy Trial of BV100 in Combination With Low Dose Polymyxin B Plus Ceftazidime/Avibactam, or Plus Cefiderocol Versus Best Available Therapy in Patients With Hospital-acquired Bacterial Pneumonia, Ventilator-associated Bacterial Pneumonia and Bloodstream Infection, Suspected or Confirmed to be Due to Carbapenem-resistant Acinetobacter Baumannii Calcoaceticus Complex (CRABC), and Secondly to Evaluate the Pharmacokinetics of BV100 in Combination With Low Dose Polymyxin B Plus Cefideroc

NCT07431307 is registered in ClinicalTrials.gov with BioVersys AG as lead sponsor.

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Registry record

As filed in ClinicalTrials.gov.

Title
A Two-part Phase IIb Randomized, Multicenter, Open-label Comparative Study to Firstly Evaluate the Safety and Efficacy Trial of BV100 in Combination With Low Dose Polymyxin B Plus Ceftazidime/Avibactam, or Plus Cefiderocol Versus Best Available Therapy in Patients With Hospital-acquired Bacterial Pneumonia, Ventilator-associated Bacterial Pneumonia and Bloodstream Infection, Suspected or Confirmed to be Due to Carbapenem-resistant Acinetobacter Baumannii Calcoaceticus Complex (CRABC), and Secondly to Evaluate the Pharmacokinetics of BV100 in Combination With Low Dose Polymyxin B Plus Cefideroc
Lead sponsor
BioVersys AG
Phase
Phase 2
Overall status
Not yet recruiting
Start date
July 31, 2026
Completion date
July 31, 2028
Enrollment
120 (estimated)
Sites
Not reported

Conditions

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

blood stream infection, hospital acquired bacterial pneumonia (habp), meningitis, bacterial, ventilator associated bacterial pneumonia (vabp), ventriculitis, infectious