Actively Recruiting
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
Led by BioVersys SAS · Updated on 2026-05-04
248
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
B
BioVersys SAS
Lead Sponsor
B
BioVersys AG
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent or legally authorized representative consent.
- Male or female patients aged 18 to 82 years at consent.
- Confirmed diagnosis of hospital-acquired or ventilator-associated bacterial pneumonia requiring IV antibiotics.
- High likelihood of pneumonia due to carbapenem-resistant Acinetobacter baumannii-calcoaceticus complex as a single or part of polymicrobial infection based on recent rapid diagnostic tests.
- Received no more than 48 hours of active antimicrobial treatment against CRABC before the first study dose or are clinically failing prior treatment.
- APACHE II score less than 30 or qSOFA score 2 or higher at screening.
- Women of childbearing potential must have a negative pregnancy test before randomization and agree to use effective contraception during and for 30 days after treatment.
- Diagnosed specifically with HABP or VABP.
You will not qualify if you...
- For Part A, infection resistant to colistin, intolerance to polymyxins, or taking drugs preventing polymyxin use.
- Active concurrent pneumonia requiring treatment caused by other listed pathogens.
- Pulmonary diseases preventing therapeutic response evaluation.
- Pleural empyema unless drained within 24 hours and treatable within 14 days.
- Solid organ transplant within 6 months.
- Deep-seated infections requiring prolonged therapy.
- Acute infective endocarditis needing urgent surgery or contraindicated for surgery.
- Surgical wound infections needing further surgery.
- Peritonitis.
- Irremovable implantable device or line source of ABC infection.
- Known or suspected neuropathy or neuromuscular disease.
- HIV infection.
- Chronic immunosuppression.
- Bronchial obstruction or history of post obstructive pneumonia.
- Patients deemed to have no potential benefit or receiving palliative care.
- Sustained shock needing vasopressors.
- Diagnosis of ventilator-associated tracheobronchitis.
- Inability to provide proper respiratory specimens.
- Received more than 48 hours of active CRABC treatment prior to study drug.
- Allergy to polymyxin, rifabutin, colistin, ampicillin/sulbactam, meropenem or excipients.
- Acute graft-versus-host disease grade 3 or higher.
- Requirement for certain prohibited treatments during the study.
- Need for additional systemic Gram-negative antimicrobial therapy active against CRABC during study.
- Expected survival less than 72 hours or Do Not Resuscitate order.
- Burns over 40% of body surface area.
- Neutropenia with absolute neutrophil count below 1500/mm3.
- Severe renal disease or dialysis requirement.
- Significant liver disease or dysfunction.
- Clinically significant ECG abnormalities.
- QTcF interval over 500 ms confirmed.
- Recent stroke with poor survival prognosis.
- Pregnant or nursing women.
- Participation in other investigational studies within 30 days or 5 half-lives.
- Unwillingness or inability to comply with study protocol.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University Hospital
Tbilisi, Georgia
Actively Recruiting
Research Team
G
Glenn Dale
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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