Safety, Pharmacokinetics and Efficacy of BV100 Plus Low Dose Polymyxin B Plus Ceftazidime/Avibactam, or Plus Cefiderocol in Patients With Pulmonary and Extrapulmonary Infections Due to Carbapenem-resistant Acinetobacter Baumannii-calcoaceticus Complex

NCT07431307 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: BV100-0122026-525542-30-00
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

This Phase IIb study aims to evaluate the safety and efficacy of BV100 in combination with low dose polymyxin B plus ceftazidime/avibactam or cefiderocol in patients with suspected or confirmed CRABC infections. The study is divided into two parts (Part A and Part B), recruiting in parallel. Approximately 10 subjects will be recruited in Part B, with enrollment ending once Part A enrollment is complete (at least 30 patients randomized to all of the three groups). Eligible patients, who have given informed consent, will be enrolled, and pre-treatment microbiology samples submitted to a local laboratory.

Conditions

Ventilator Associated Bacterial Pneumonia (VABP); Hospital Acquired Bacterial Pneumonia (HABP); Blood Stream Infection; Meningitis, Bacterial; Ventriculitis, Infectious

Keywords

VABP; BV100; HABP; BSI; CNS infection; BioVersys

Outcome Measures

Primary Outcomes (1)

• The incidence of treatment-related treatment emergent adverse events (TRTEAEs) in the Safety population, assessed through End of Study (EoS) visit in Part A and Part B.

  30 days

Secondary Outcomes (4)

• 28-day all cause mortality (ACM) in the CRABC m-MITT Population in Part A.

  28 days

• Clinical cure at Test of Cure (ToC) in the CRABC m-MITT population in Part A.

  21 days

• Concentration of rifabutin and 25-O-deacetyl-rifabutin in CSF and plasma at steady state in Part B

  7 days

• 14-day all cause mortality (ACM) in the CRABC m-MITT Population in Part A.

  14 days

Study Arms (4)

Part A - Group 1

EXPERIMENTAL

Drug: BV100 with 50 mg polymyxin B plus ceftazidime/avibactam

Part A - Group 2

EXPERIMENTAL

Drug: BV100 with 50 mg polymyxin B plus cefiderocol

Part A - Group 3

ACTIVE COMPARATOR

Drug: Best Available Therapy (BAT)

Part B

EXPERIMENTAL

Drug: BV100 with 50 mg polymyxin B plus cefiderocol

Interventions

BV100 with 50 mg polymyxin B plus ceftazidime/avibactam DRUG

300 mg BV100 in combination with 500,000 IU (50 mg) polymyxin B infused over 2 hours every 12 hours (q12h), plus 2 g/0.5 g ceftazidime/avibactam\*,# infused over 2 hours every 8 hours (q8h).

Part A - Group 1

BV100 with 50 mg polymyxin B plus cefiderocol DRUG

300 mg BV100 in combination with 500,000 IU (50 mg) polymyxin B infused over 2 hours every 12 hours (q12h), plus 2 g cefiderocol infused over 3 hours every 8 hours (q8h).

Part A - Group 2; Part B

Best Available Therapy (BAT) DRUG

Best Available Therapy (BAT), which is determined by the site for each individual patient according to local epidemiology and the patient's antibiotic history.

Part A - Group 3

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. Surrogate consent/use of a legally authorized representative may be provided if permitted by local country and institution-specific guidelines
• Male subjects or female subjects ≥ 18 and ≤ 82 years of age at the time of signing informed consent.
• A known or highly suspected infection caused by CRABC (VABP, HABP, or BSI of non-urinary tract origin) as either a single pathogen or member of a polymicrobial infection
• Diagnosed with HABP, VABP or BSI
• Acute Physiology and Chronic Health Evaluation (APACHE II) score ≤ 30, within 24 hours prior to randomization.
• Confirmed CRABC ventriculitis or meningitis based on evidence from CSF culture collected within 72 hours prior to enrollment (as per standard of care).
• Functioning EVD that can be used for safe and timely CSF sampling.
• No contraindications to CSF sampling via EVD in the volumes required by the protocol

You may not qualify if:

• \. Urinary tract infection as source of A. baumannii BSI2. Known or suspected community acquired bacterial pneumonia or viral (including SARS-CoV-2), pneumonia within the last 7 days 3. Known or suspected viral pneumonia within the last 7 days before screening e.g. positive for SARS-CoV-2 or influenza.
• \. Known fungal or parasitic pneumonia. 5. 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 as receiving palliative or comfort-focused care.
• \. Sustained shock with persisting hypotension requiring vasopressors to maintain mean arterial pressure ≥ 65 mmHg (calculate mean arterial pressure = diastolic pressure plus 1/3 (systolic pressure minus diastolic pressure)) with patients requiring escalating vasopressor support to maintain adequate arterial pressure in conjunction with rising lactate.7. Known or suspected allergies to polymyxins, rifabutin, ceftazidime/avibactam, cefiderocol, or their excipients.
• \. Inability to insert a central catheter or a peripherally inserted central catheter (PICC).11. Acute graft versus host disease Grade ≥ 3.
• \. Expected survival \< 72 hours or a Do Not Resuscitate Order. 13. Burns \> 40% of total body surface area. 14. Presence of neutropenia (absolute neutrophil count \< 1500/mm3) obtained from a local laboratory at Screening, or anticipated neutropenia with absolute neutrophil count \< 1500 cells/mm3.
• \. Severe renal disease defined as an estimated glomerular filtration rate (eGFR) as per Modification of Diet in Renal Disease (MDRD) formula (MDRD eGFR) \< 30 mL/min/1.73 m2, or requirement for peritoneal dialysis, hemodialysis, hemofiltration, or a urine output \< 20 mL/hour over a 24 hour period.

Sponsors & Collaborators

• BioVersys AG: lead

MeSH Terms

Conditions

Meningitis, Bacterial; Cerebral Ventriculitis; Central Nervous System Infections

Interventions

Polymyxin B; Ceftazidime; avibactam; Cefiderocol

Condition Hierarchy (Ancestors)

Central Nervous System Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Central Nervous System Diseases; Nervous System Diseases; Meningitis; Neuroinflammatory Diseases; Central Nervous System Viral Diseases; Encephalitis; Brain Diseases

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; Cephaloridine; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2026
• First Posted: February 24, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: February 24, 2026

Record last verified: 2026-02