Overview

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-calcoa

Status:
NOT_YET_RECRUITING

Trial end date:
2028-03-30

Target enrollment:

Participant gender:

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.

Phase:

PHASE3

Details

Lead Sponsor:

BioVersys SAS

Collaborator:

BioVersys AG

Treatments:

Colistin
Polymyxin B
sultamicillin