drugset / Trial / NCT07326540
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
RandomizedParallel-groupSingle-blindTreatment
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.
Timeline
- Start
- 2026-03-27
- Primary completion
- 2027-12-30
- Completion
- 2028-03-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ampicillin | Unknown | 6 g | Intravenous |
| Comparator | Colistin | Other / unclassified | 4.5e+06 iu | Intravenous |
| Subject | Polymyxin B | Peptide | 50 mg | Intravenous |
| Subject | Rifabutin | Small molecule | 300 mg | Intravenous |
| Comparator | Sulbactam | Small molecule | 3 g | Intravenous |
| Background | Meropenem | Small molecule | 2 g | Intravenous |