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

Recruiting now · Phase 3

Conditions studied: Hospital Acquired Bacterial Pneumonia (HABP), Ventilator Associated Bacterial Pneumonia (VABP), Colistin Resistanrt ABC, Acinetobacter Baumannii-calcoaceticus Complex

In brief

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.

Key facts

Study ID

NCT07326540

Run by

BioVersys SAS

People needed

248

Starts

2026-03-27

Expected to finish

2028-03-30

Last updated by the study team

2026-05-04

Who can join

Age: 18 and older, up to 82. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Provide written informed consent prior to any study related procedures not part of normal medical care. If permitted by local country and institution-specific guidelines, surrogate consent/use of a legally authorized representative may be provided. Alternatively, the decision can be made according to the procedure permitted by local law and institutional Standard Operating Procedures. If a patient regains consciousness while in the study and, per the Investigator's judgment, the patient is able to read, assess, understand, and make his/her own decision to participate in the study, the patient may agree to continue participation. In such cases, the patient must be reconsented.
• Male or female patients, ≥ 18 and ≤ 82 years of age at the time of signing informed consent.
• A confirmed diagnosis of HABP or VABP requiring treatment with IV antibiotics in the judgment of the Investigator.
• High probability of a pneumonia (HABP or VABP) due to ABC as a single pathogen, or member of a polymicrobial infection based on evidence from RDT from a sample collected within 48 hours prior to randomization, AND one of the following:
• Has received no more than 48 hours of potentially active antimicrobial treatment against CRABC prior to the first dose of study drug; OR
• Is clinically failing prior treatment regimens (i.e., clinical deterioration or failure to improve after at least 48 hours of antibiotic treatment).
• An APACHE II < 30 or qSOFA score ≥ 2 at Screening.
• Women of childbearing potential must have a negative highly sensitive urine or serum pregnancy test before randomization. Participating women of childbearing potential must be willing to consistently use one highly effective method of contraception from Screening until at least 30 days after administration of the last dose of study drug.
• Diagnosed with HABP or VABP

You may not qualify if…

• For Part A only, patients with an infection known to be resistant to colistin, with a known intolerance to polymyxins, or taking any drug that prevents them from receiving polymyxins.
• Evidence of active concurrent pneumonia requiring additional antimicrobial treatment caused by, e.g., Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Mycoplasma pneumoniae, Chlamydia pneumoniae, Legionella pneumophila, Pneumocystitis jiroveci, Aspergillus spp, respiratory syncytial virus, influenza and parainfluenza viruses, Middle East respiratory syndrome coronavirus, mycobacteria, mucormycosis.
• Any of the following health conditions:
• Pulmonary disease that precludes evaluation of a therapeutic response.
• Pleural empyema (exception: acceptable if drainage occurs within 24 hours of Screening and patient is expected to be treated in ≤ 14 days).
• Solid organ transplant within 6 months prior to randomization.
• Evidence of deep seated infection, e.g., Gram-negative osteomyelitis, or meningitis requiring prolonged therapy.
• Acute infective endocarditis due to Gram-positive bacteria that requires urgent treatment/emergent indication of surgery, or patients in whom surgery is contraindicated due to prohibitive risk for surgery due to comorbidities.
• Surgical wound infections requiring further surgical management e.g., wound closure, drain removal.
• Peritonitis.
• Irremovable implantable device or line thought to be the source of the ABC infection.
• Known or suspected neuropathy or neuromuscular disease.
• Human immunodeficiency virus infection.
• Chronic immunosuppression due to drugs and/or underlying disease
• Bronchial obstruction or a history of post obstructive pneumonia (this does not exclude patients with pneumonia who have an underlying chronic obstructive pulmonary disease).
• Patients classified under futility of care, as determined by the medical team, indicating a lack of potential for benefit from intervention or patients who are permanent residents of long-term care facilities and have been assessed by the clinical team as receiving palliative or comfort-focused care.
• Sustained shock with persisting hypotension requiring vasopressors to maintain mean arterial pressure ≥ 65 mmHg
• Diagnosis of ventilator-associated tracheobronchitis.
• Inability to provide proper respiratory specimens for culture.
• Received more than 48 hours of potentially active treatment against CRABC prior to the first dose of study drug.
• Known or suspected allergy to polymyxin, rifabutin, colistin, ampicillin/sulbactam, meropenem or their excipients.
• Acute graft-versus-host disease (Grade ≥ 3).
• Requirement for continuing treatment with probenecid, methotrexate, ganciclovir, valproic acid, or divalproex sodium during the study.
• Requirement at the time of randomization for any reason, or likely to require during the patient's participation in the study (from randomization through the EoS Visit), for additional systemic Gram-negative antimicrobial therapy potentially active toward CRABC.
• Expected survival < 72 hours or a Do Not Resuscitate Order.

Where it is running

• University Hospital — Tbilisi, Georgia (enrolling)

Full record on ClinicalTrials.gov

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