Not Yet RecruitingPhase 2

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

120 participantsStarted 2026-07

Plain-language 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.

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. 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

What they're measuring

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.

Timeframe: 30 days

Trial details

NCT IDNCT07431307

SponsorBioVersys AG

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-03

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