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

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

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-82

SponsorBioVersys AG

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

None

Trial design

Treatments tested in this trial

BV100 with 50 mg polymyxin B plus ceftazidime/avibactam
BV100 with 50 mg polymyxin B plus cefiderocol
Best Available Therapy (BAT)

Treatment groups

120 Participants

are divided into 4 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

BioVersys AG

Lead sponsor

Source ClinicalTrials.gov