Health TrialsbyHealthPanel

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

ConditionsHospital Acquired Bacterial Pneumonia (HABP)Ventilator Associated Bacterial Pneumonia (VABP)Colistin Resistanrt ABCAcinetobacter Baumannii-calcoaceticus Complex
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-82
SponsorBioVersys SAS

About this trial

This is a two-part study, with Part A being the randomized, controlled portion of the study in patients with hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP) suspected or confirmed to be due to carbapenem-resistant Acinetobacter baumannii-calcoaceticus complex (CRABC).

Part B is the single-group portion of the study and includes patients with HABP or VABP with CRABC infections that are resistant to or have failed colistin/polymyxin B treatment.

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. If permitted by local country and institution-specific guidelines, surrogate consent/use of a legally authorized representative may be provided. Alternatively, the decision can be made according to the procedure permitted by local law and institutional Standard Operating Procedures. If a patient regains consciousness while in the study and, per the Investigator's judgment, the patient is able to read, assess, understand, and make his/her own decision to participate in the study, the patient may agree to continue participation. In such cases, the patient must be reconsented.

Male or female patients, ≥ 18 and ≤ 82 years of age at the time of signing informed consent.

A confirmed diagnosis of HABP or VABP requiring treatment with IV antibiotics in the judgment of the Investigator.

Has received no more than 48 hours of potentially active antimicrobial treatment against CRABC prior to the first dose of study drug; OR

Disqualifiers

For Part A only, patients with an infection known to be resistant to colistin, with a known intolerance to polymyxins, or taking any drug that prevents them from receiving polymyxins.

Evidence of active concurrent pneumonia requiring additional antimicrobial treatment caused by, e.g., Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Mycoplasma pneumoniae, Chlamydia pneumoniae, Legionella pneumophila, Pneumocystitis jiroveci, Aspergillus spp, respiratory syncytial virus, influenza and parainfluenza viruses, Middle East respiratory syndrome coronavirus, mycobacteria, mucormycosis.

Pulmonary disease that precludes evaluation of a therapeutic response.

Pleural empyema (exception: acceptable if drainage occurs within 24 hours of Screening and patient is expected to be treated in ≤ 14 days).

Trial design

Design model

Parallel

Treatments tested in this trial

  • BV100 (300 mg)

    Drug

    300 mg BV100 nfused over 2 hours every 12 hours (q12h).Treatment for 7 days up to 14 days if clinically indicated.

  • Polymyxin B

    Drug

    50 mg polymyxin B infused over 2 hours every 12 hours (q12h).Treatment for 7 days up to 14 days if clinically indicated.

  • Colistin

    Drug

    Colistin (4,500,000 units infused over 1 hour every 12 hours (q12h), after an initial loading dose of 9,000,000 units infused over 1 hour).Treatment for 7 days up to 14 days if clinically indicated.

  • Ampicillin-Sulbactam

    Drug

    High dose ampicillin/sulbactam (6 g/3 g IV over 4 hours q8h).Treatment for 7 days up to 14 days if clinically indicated.

  • MEROPENEM 2 grams TID

    Drug

    meropenem infused over 1 hour every 8 hours (q8h).Treatment for 7 days up to 14 days if clinically indicated.

Treatment groups

248 Participants
are divided into 3 treatment groups
Group A: Part A - Group 1: BV100 (rifabutin for infusion) plus low dose polymyxin BExperimental treatment 3 interventions
Group B: Part A-Group 2: Colistin plus high dose ampicillin/sulbactamActive comparator 3 interventions
Group C: Part B-Group 3: BV100 (rifabutin for infusion) plus low dose polymyxin BExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

The proportion of patients with All-Cause Mortality in CRABC m-MITT Population

The primary efficacy endpoint for the study is 28-day all-cause mortality (ACM) in the CRABC Microbiological Modified Intention-to-Treat (CRABC m-MITT) population in Part A.

Time frame
Day 28

Secondary outcomes

1

Proportion of Patients with clinical cure at ToC in CRABC m-MITT Population

Clinical cure status (cure, failure, indeterminate) will be assessed at the ToC in CRABC m-MITT Population in Part A

Time frame
7 days after end of treatment

Other outcomes

Sponsors and contacts

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

BioVersys SAS

Lead sponsor

BioVersys AG

Collaborator

Source ClinicalTrials.gov
Apply now