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

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

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 248 (estimated)
• Sponsor: BioVersys SAS · Industry
• Sex: All
• Age: 18 Years – 82 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a Phase 3, randomized, active-controlled two-part parallel-group study to evaluate the efficacy and safety of BV100 plus low-dose polymyxin B in patients with HABP or VABP suspected or confirmed to be due to CRABC infection. Eligible patients who provide informed consent will be enrolled in the study and will have pretreatment blood and infection site-specific samples collected and submitted to a local laboratory. The overall study design consists of two parts in which patients will be recruited in parallel. Part A is the pivotal, randomized, comparative portion of the study, focusing on patients with suspected or confirmed CRABC HABP or VABP. Part A of the study will employ a partially blinded design. Site personnel directly involved in patient care and treatment administration will be unblinded to treatment assignment; however, access to treatment allocation information, including data potentially revealing assigned treatment arm, will be restricted for Sponsor study personnel. No personnel employed at the Sponsor will have access to the data, maintaining blinding for all Sponsor employees. Project management and oversight and medical query management will be conducted by unblinded external providers or vendors. The Central Adjudication Committee (CAC) will be the blinded assessor. Part B is a prospective multicenter, open-label, nonrandomized, additional single group to evaluate the efficacy and safety of BV100 plus low-dose polymyxin B in patients with HABP or VABP due to CRABC known to be resistant to colistin or polymyxin B prior to study entry and patients where colistin or polymyxin B regimen has failed prior to study entry. Approximately 25 patients are expected to be enrolled in Part B. Patients randomized to either group of Part A cannot be transferred to Part B.

Conditions

• Hospital Acquired Bacterial Pneumonia (HABP)
• Ventilator Associated Bacterial Pneumonia (VABP)
• Colistin Resistanrt ABC
• Acinetobacter Baumannii-calcoaceticus Complex

Interventions

Type	Name	Description
DRUG	BV100 (300 mg)	300 mg BV100 nfused over 2 hours every 12 hours (q12h).Treatment for 7 days up to 14 days if clinically indicated.
DRUG	Polymyxin B	50 mg polymyxin B infused over 2 hours every 12 hours (q12h).Treatment for 7 days up to 14 days if clinically indicated.
DRUG	Colistin	Colistin (4,500,000 units infused over 1 hour every 12 hours (q12h), after an initial loading dose of 9,000,000 units infused over 1 hour).Treatment for 7 days up to 14 days if clinically indicated.
DRUG	Ampicillin-Sulbactam	High dose ampicillin/sulbactam (6 g/3 g IV over 4 hours q8h).Treatment for 7 days up to 14 days if clinically indicated.
DRUG	MEROPENEM 2 grams TID	meropenem infused over 1 hour every 8 hours (q8h).Treatment for 7 days up to 14 days if clinically indicated.

Timeline

• Start date: 2026-03-20
• Primary completion: 2027-12-01
• Completion: 2028-03-30
• First posted: 2026-01-08
• Last updated: 2026-01-08

Regulatory

• FDA-regulated drug study