deltatrials
Completed PHASE2 INTERVENTIONAL 4-arm NCT05685615

PK of BV100 in Patients VABP Suspected or Confirmed to Be Due to CRAB

A Multicenter, Open-label, Randomized, Active-controlled, Phase 2 Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Intravenous BV100 Combined with Polymyxin B Versus Best Available Therapy in Adult Patients with Ventilator-associated Bacterial Pneumonia Suspected or Confirmed to Be Due to Carbapenem-resistant Acinetobacter Baumannii

Sponsor: BioVersys AG

Conditions Ventilator Associated Pneumonia
Interventions BAT BV100 plus Polymyxin B
Updated 8 times since 2023 Last updated: Jan 12, 2025 Started: Apr 20, 2023 Primary completion: Nov 1, 2024 Completion: Dec 11, 2024
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE2 trial investigates Ventilator Associated Pneumonia and is currently completed. BioVersys AG leads this study, which shows 8 recorded versions since 2023 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Study Description(click to expand)

A multicenter, open label, randomized, active controlled, Phase 2 study to evaluate the pharmacokinetics, efficacy, and safety of intravenous BV100 combined with Polymyxin B versus best available therapy in adult patients with ventilator associated bacterial pneumonia suspected or confirmed to be due to carbapenem-resistant Acinetobacter baumannii

A multicenter, open label, randomized, active controlled, Phase 2 study to evaluate the pharmacokinetics, efficacy, and safety of intravenous BV100 combined with Polymyxin B versus best available therapy in adult patients with ventilator associated bacterial pneumonia suspected or confirmed to be due to carbapenem-resistant Acinetobacter baumannii

Status Flow

~Feb 2023 – ~Jun 2023 · 4 months · monthly snapshotNot Yet Recruiting~Jun 2023 – ~Dec 2023 · 6 months · monthly snapshotRecruiting~Dec 2023 – ~Jul 2024 · 7 months · monthly snapshotRecruiting~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Nov 2024 · 2 months · monthly snapshot~Nov 2024 – ~Feb 2025 · 3 months · monthly snapshotActive Not Recruiting~Feb 2025 – ~Sep 2025 · 7 months · monthly snapshotCompleted~Sep 2025 – present · 7 months · monthly snapshotCompleted

Change History

8 versions recorded

  1. Sep 2025 — Present [monthly]

    Completed PHASE2

  2. Feb 2025 — Sep 2025 [monthly]

    Completed PHASE2

    Status: Active Not Recruiting → Completed

  3. Nov 2024 — Feb 2025 [monthly]

    Active Not Recruiting PHASE2

    Status: Recruiting → Active Not Recruiting

  4. Sep 2024 — Nov 2024 [monthly]

    Recruiting PHASE2

  5. Jul 2024 — Sep 2024 [monthly]

    Recruiting PHASE2

▶ Show 3 earlier versions

  1. Dec 2023 — Jul 2024 [monthly]

    Recruiting PHASE2

  2. Jun 2023 — Dec 2023 [monthly]

    Recruiting PHASE2

    Status: Not Yet Recruiting → Recruiting

  3. Feb 2023 — Jun 2023 [monthly]

    Not Yet Recruiting PHASE2

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • BioVersys AG
Data source: BioVersys AG

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations