NCT05685615

PK of BV100 in Patients VABP Suspected or Confirmed to Be Due to CRAB

A Multicenter, Open-label, Randomized, Active-controlled, Phase 2 Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Intravenous BV100 Combined with Polymyxin B Versus Best Available Therapy in Adult Patients with Ventilator-associated Bacterial Pneumonia Suspected or Confirmed to Be Due to Carbapenem-resistant Acinetobacter Baumannii

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: BioVersys AG · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

A multicenter Phase 2 study to evaluate the pharmacokinetics, efficacy, and safety of intravenous BV100 combined with Polymyxin B in adult patients with VABP suspected or confirmed to be due to CRAB

Detailed description

A multicenter, open label, randomized, active controlled, Phase 2 study to evaluate the pharmacokinetics, efficacy, and safety of intravenous BV100 combined with Polymyxin B versus best available therapy in adult patients with ventilator associated bacterial pneumonia suspected or confirmed to be due to carbapenem-resistant Acinetobacter baumannii

Conditions

• Ventilator Associated Pneumonia

Interventions

Type	Name	Description
DRUG	BV100 plus Polymyxin B	Rifabutin for Infusion plus Polymyxin B for Injection
DRUG	BAT	The best avaialble antibiotic therapy to treat CRAB

Timeline

• Start date: 2023-04-20
• Primary completion: 2024-11-01
• Completion: 2024-12-11
• First posted: 2023-01-17
• Last updated: 2025-01-14

Locations

16 sites across 3 countries: Georgia, Greece, Hungary