Health Trials

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

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

Treatments tested in this trial

  • BV100 (300 mg)
  • Polymyxin B
  • Colistin
  • Ampicillin-Sulbactam
  • MEROPENEM 2 grams TID

Treatment groups

248 Participants
are divided into 3 treatment groups

Sponsors and collaborators

BioVersys SAS

Lead sponsor

BioVersys AG

Collaborator

Source ClinicalTrials.gov