Efficacy and Safety of BV100 Plus Low Dose Polymyxin B Versus Colistin Plus High-dose Ampicillin/… (NCT07326540) | Clinical Trial Compass
RecruitingPhase 3
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
Georgia248 participantsStarted 2026-03-27
Plain-language 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.
Who can participate
Age range18 Years – 82 Years
SexALL
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Inclusion criteria
✓. 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).
What they're measuring
1
The proportion of patients with All-Cause Mortality in CRABC m-MITT Population
. 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.
Exclusion criteria
✕. 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.
✕. 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.