Trials / Not Yet Recruiting
Not Yet RecruitingNCT07431307
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
A Two-part Phase IIb Randomized, Multicenter, Open-label Comparative Study to Firstly Evaluate the Safety and Efficacy Trial of BV100 in Combination With Low Dose Polymyxin B Plus Ceftazidime/Avibactam, or Plus Cefiderocol Versus Best Available Therapy in Patients With Hospital-acquired Bacterial Pneumonia, Ventilator-associated Bacterial Pneumonia and Bloodstream Infection, Suspected or Confirmed to be Due to Carbapenem-resistant Acinetobacter Baumannii Calcoaceticus Complex (CRABC), and Secondly to Evaluate the Pharmacokinetics of BV100 in Combination With Low Dose Polymyxin B Plus Cefideroc
- Status
- Not Yet Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- Sponsor
- BioVersys AG · Industry
- Sex
- All
- Age
- 18 Years – 82 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
Part A will be the randomized, active-controlled portion of the study, evaluating patients with suspected or confirmed CRABC nosocomial pneumonia (VABP and HABP) and BSI of non-urinary tract origin. This is an open-label study, and therefore, no blinding will be done. In Part A, patients will be randomized 1:1:1, to one of the three treatment groups until the CRABC m-MITT population includes 30 evaluable subjects per group: * Group 1: 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). * Group 2: 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). * Group 3: Best Available Therapy (BAT), which is determined by the site for each individual patient according to local epidemiology and the patient's antibiotic history. * In case of non-Acinetobacter metallo-beta-lactamase (MBL)-producing infections confirmed by culture or identified by RDT, including polymicrobial infections,, aztreonam (2 g infused over 2 hours, q8h) should be infused simultaneously with ceftazidime-avibactam via a Y-site administration used per manufacturer's instructions, subject to Medical Monitor approval. * If rapid diagnostic test (RDT) on positive blood culture broths show Acinetobacter only, concomitant ceftazidime-avibactam can be omitted. In Part A, no more than 30 patients with HABP will be enrolled across all treatment groups. Part B is a prospective multicenter, open label, non-randomized, additional single cohort to evaluate the PK, safety, and efficacy BV100 in combination with both low dose polymyxin B and cefiderocol in patients with CRABC ventriculitis or meningitis. Optional intrathecal or intraventricular administration of polymyxin B or colistin, as well as dexamethasone therapy per local treatment standards, is permitted. After 14 days of treatment with BV100 and low dose polymyxin B, the BV100 therapy must be stopped, but patients may continue therapy with cefiderocol and best available additional therapy at the discretion of the investigator and as needed. Functioning external ventricular drains (EVDs) are required for safe and timely CSF sampling. Approximately 10 patients are expected to be enrolled in part B, with enrollment concluding once the last patient in Part A is recruited.
Conditions
- Ventilator Associated Bacterial Pneumonia (VABP)
- Hospital Acquired Bacterial Pneumonia (HABP)
- Blood Stream Infection
- Meningitis, Bacterial
- Ventriculitis, Infectious
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BV100 with 50 mg polymyxin B plus ceftazidime/avibactam | 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). |
| DRUG | BV100 with 50 mg polymyxin B plus cefiderocol | 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). |
| DRUG | Best Available Therapy (BAT) | Best Available Therapy (BAT), which is determined by the site for each individual patient according to local epidemiology and the patient's antibiotic history. |
Timeline
- Start date
- 2026-07-01
- Primary completion
- 2028-03-01
- Completion
- 2028-07-01
- First posted
- 2026-02-24
- Last updated
- 2026-02-24
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07431307. Inclusion in this directory is not an endorsement.