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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

NCT07326540 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 248

Last updated 2026-05-04

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • BioVersys AG

    collaborator INDUSTRY

  • BioVersys SAS

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
82 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-27
Primary Completion
2027-12-30
Completion
2028-03-30
FDA Drug
Yes

Countries

  • Georgia

Study Locations

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Drugs
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07326540 on ClinicalTrials.gov