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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 InfectionMeningitis, BacterialVentriculitis, 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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • BV100 with 50 mg polymyxin B plus ceftazidime/avibactam

    Drug

    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).

  • BV100 with 50 mg polymyxin B plus cefiderocol

    Drug

    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).

  • Best Available Therapy (BAT)

    Drug

    Best Available Therapy (BAT), which is determined by the site for each individual patient according to local epidemiology and the patient's antibiotic history.

Treatment groups

120 Participants
are divided into 4 treatment groups
Group A: Part A - Group 1Experimental treatment 1 intervention
Group B: Part A - Group 2Experimental treatment 1 intervention
Group C: Part A - Group 3Active comparator 1 intervention
Group D: Part BExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
30 days

Secondary outcomes

1

28-day all cause mortality (ACM) in the CRABC m-MITT Population in Part A.

Time frame
28 days
2

Clinical cure at Test of Cure (ToC) in the CRABC m-MITT population in Part A.

Time frame
21 days
3

Concentration of rifabutin and 25-O-deacetyl-rifabutin in CSF and plasma at steady state in Part B

Time frame
7 days
4

14-day all cause mortality (ACM) in the CRABC m-MITT Population in Part A.

Time frame
14 days

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

BioVersys AG

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: