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 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: BV100-010
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

BV100; CRABC; VABP; HABP; polymyxin B; colistin

Outcome Measures

Primary Outcomes (1)

• The proportion of patients with All-Cause Mortality in CRABC m-MITT Population

  The primary efficacy endpoint for the study is 28-day all-cause mortality (ACM) in the CRABC Microbiological Modified Intention-to-Treat (CRABC m-MITT) population in Part A.

  Day 28

Secondary Outcomes (1)

• Proportion of Patients with clinical cure at ToC in CRABC m-MITT Population

  7 days after end of treatment

Study Arms (3)

Part A - Group 1: BV100 (rifabutin for infusion) plus low dose polymyxin B

EXPERIMENTAL

Part A is the pivotal, assessor-blind, randomized, comparative portion of the study in patients with documented ABC hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP). Part A - Group 1 (experimental): 300 mg BV100 plus 50 mg polymyxin B infused over 2 hours every 12 hours (q12h), plus 2 g meropenem infused over 1 hour every 8 hours (q8h)

Drug: BV100 (300 mg); Drug: Polymyxin B; Drug: MEROPENEM 2 grams TID

Part A-Group 2: Colistin plus high dose ampicillin/sulbactam

ACTIVE COMPARATOR

Part A - Group 1 (control group): Colistin (4,500,000 units intravenously \[IV\] over 1 hour q12h, after an initial loading dose of 9,000,000 units infused over 1 hour) plus high dose ampicillin/sulbactam (6 g/3 g IV over 4 hours q8h, plus 2 g meropenem infused over 1 hour every 8 hour (q8h).

Drug: Colistin; Drug: Ampicillin-Sulbactam; Drug: MEROPENEM 2 grams TID

Part B-Group 3: BV100 (rifabutin for infusion) plus low dose polymyxin B

EXPERIMENTAL

Part B (Group 3) is the open-label, nonrandomized supportive portion of the study that includes patients known to have HABP or VABP associated with ABC organaisms resistant to colistin or polymyxin B, or who have who have failed a colistin or polymyxin B regimen prior to study entry. Part B - Group 3: 300 mg BV100 plus 50 mg polymyxin B infused over 2 hours every 12 hours (q12h), plus 2 g meropenem infused over 1 hour every 8 hours (q8h).

Drug: BV100 (300 mg); Drug: Polymyxin B; Drug: MEROPENEM 2 grams TID

Interventions

BV100 (300 mg) DRUG

300 mg BV100 nfused over 2 hours every 12 hours (q12h).Treatment for 7 days up to 14 days if clinically indicated.

Part A - Group 1: BV100 (rifabutin for infusion) plus low dose polymyxin B; Part B-Group 3: BV100 (rifabutin for infusion) plus low dose polymyxin B

Polymyxin B DRUG

50 mg polymyxin B infused over 2 hours every 12 hours (q12h).Treatment for 7 days up to 14 days if clinically indicated.

Part A - Group 1: BV100 (rifabutin for infusion) plus low dose polymyxin B; Part B-Group 3: BV100 (rifabutin for infusion) plus low dose polymyxin B

Colistin DRUG

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.

Part A-Group 2: Colistin plus high dose ampicillin/sulbactam

Ampicillin-Sulbactam DRUG

High dose ampicillin/sulbactam (6 g/3 g IV over 4 hours q8h).Treatment for 7 days up to 14 days if clinically indicated.

Part A-Group 2: Colistin plus high dose ampicillin/sulbactam

MEROPENEM 2 grams TID DRUG

meropenem infused over 1 hour every 8 hours (q8h).Treatment for 7 days up to 14 days if clinically indicated.

Part A - Group 1: BV100 (rifabutin for infusion) plus low dose polymyxin B; Part A-Group 2: Colistin plus high dose ampicillin/sulbactam; Part B-Group 3: BV100 (rifabutin for infusion) plus low dose polymyxin B

Eligibility Criteria

• Age: 18 Years - 82 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• BioVersys SAS: lead
• BioVersys AG: collaborator

Study Sites (1)

University Hospital

Tbilisi, Georgia

RECRUITING

MeSH Terms

Interventions

Polymyxin B; Colistin; sultamicillin

Intervention Hierarchy (Ancestors)

Polymyxins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Lipopeptides; Lipids; Antimicrobial Cationic Peptides; Peptides; Amino Acids, Peptides, and Proteins; Antimicrobial Peptides; Pore Forming Cytotoxic Proteins; Membrane Proteins; Proteins

Central Study Contacts

Glenn Dale

CONTACT

+41 61 633 22 50; info@bioversys.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: January 8, 2026
• Study Start: March 27, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): March 30, 2028
• Last Updated: May 4, 2026

Record last verified: 2026-01

Locations

GE (1)