8 completed, 2 not yet recruiting, 1 recruiting. 6 Phase 1, 3 Phase 2, 1 Phase 3.
By phase and status
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|
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
BV100 with 50 mg polymyxin B plus ceftazidime/avibactam, BV100 with 50 mg polymyxin B plus cefiderocol, Best Available Therapy (BAT) - Ventilator Associated Bacterial Pneumonia (VABP), Hospital Acquired Bacterial Pneumonia (HABP) | Phase 2 | Not yet recruiting | BioVersys AG | 120 | 2026-07-01 | 2026-02-24 |
Phase 2a Trial of Alpibectir Plus Ethionamide for Tuberculosis Meningitis
HRZE, HRZE plus Alpe375, HRZE plus AlpE500 - Tuberculosis Meningitis | Phase 2 | Not yet recruiting | BioVersys AG | 64 | 2026-03-30 | 2026-03-03 |
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
BV100 (300 mg), Polymyxin B, Colistin - Hospital Acquired Bacterial Pneumonia (HABP), Ventilator Associated Bacterial Pneumonia (VABP) | Phase 3 | Recruiting | BioVersys SAS | 248 | 2026-03-27 | 2026-05-04 |
Study to Investigate the Penetration of Rifabutin Into the Lung After Multiple Intravenous Administrations of BV100
BV100 - Bacterial Infections | Phase 1 | Completed | BioVersys AG | 35 | 2023-09-01 | 2025-01-14 |
PK of BV100 in Patients VABP Suspected or Confirmed to Be Due to CRAB
BV100 plus Polymyxin B, BAT - Ventilator Associated Pneumonia | Phase 2 | Completed | BioVersys AG | 39 | 2023-04-20 | 2025-01-14 |
To Evaluate the Effect of Multiple Doses of Itraconazole on the Pharmacokinetics of BV100
BV100 (300 mg), Itraconazole 200 mg - Bacterial Infections | Phase 1 | Completed | BioVersys AG | 16 | 2023-02-01 | 2023-11-21 |
A Study to Assess the Phamacokinetics of BV100 in Participants with Varying Degrees of Hepatic Impairment
BV100 - Healthy Participants | Phase 1 | Completed | BioVersys AG | 33 | 2022-09-02 | 2025-01-14 |
A Study to Assess Effect of BV100 on the Pharmacokinetics of Midazolam in Healthy Participants
BV100, Midazolam - Healthy Volunteers | Phase 1 | Completed | BioVersys AG | 16 | 2022-09-01 | 2023-11-21 |
Pharmacokinetics of Ethionamide and Ethionamide Sulfoxide in Patients Established on Treatment for Tuberculosis.
Plasma samples - Tuberculosis, Pulmonary | | Completed | BioVersys AG | 30 | 2022-06-10 | 2023-11-21 |
Pharmacokinetics and Safety of BV100 Administered as Single Intravenous Infusion to Subjects With Renal Impairment
BV100 - Renal Impairment | Phase 1 | Completed | BioVersys AG | 48 | 2021-10-08 | 2023-01-18 |
Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetics of BVL-GSK098 in Healthy Volunteers
BVL-GSK098 capsule, placebo - Healthy Volunteers | Phase 1 | Completed | BioVersys AG | 80 | 2020-12-02 | 2023-01-18 |
Conditions studied
Bacterial Infections (2) · Central Nervous System Infections (1) · Cerebral Ventriculitis (1) · Meningitis, Bacterial (1) · Pneumonia, Ventilator-Associated (1) · Renal Insufficiency (1) · Tuberculosis (1) · Tuberculosis, Meningeal (1) · Tuberculosis, Pulmonary (1)
Interventions
Polymyxin B (3) · Rifabutin (3) · Cefiderocol (1) · Ceftazidime (1) · Colistin (1) · Itraconazole (1) · Midazolam (1) · avibactam (1) · sultamicillin (1)
Countries
Hungary (5) · Georgia (2) · Austria (1) · Greece (1) · South Africa (1) · Spain (1)
Top investigators
Lisa Husband, MD (3) · Geza Lakner (1) · Geza Lakner, MD (1) · Glenn Dale (1) · Rosa M Antonijoan, MD (1)
Results publications
PMID 38656557