Pivotal Study in VAP Suspected or Confirmed to be Due to Pseudomonas Aeruginosa

Study Overview
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Brief Summary
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This is a phase 3, multicenter, open-label, randomized active-controlled, parallel group to investigate the efficacy, safety and tolerability, and pharmacokinetics of intravenous murepavadin combined with of one anti-pseudononas antibiotic with that of two anti-pseudomonas antibiotics in the treatment of ventilator-associated bacterial pneumonia (VABP) in adult subjects.

Official Title
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A Multicenter, Open-label, Randomized, Active-controlled, Parallel Group, Pivotal Study to Investigate the Efficacy, Safety and Tolerability, and Pharmacokinetics of Murepavadin Combined With One Anti-pseudomonal Antibiotic Versus Two Anti-pseudomonal Antibiotics in Adult Subjects With Ventilator-associated Bacterial Pneumonia Suspected or Confirmed to be Due to Pseudomonas Aeruginosa

Conditions
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Pneumonia

Intervention / Treatment
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* Drug: Murepavadin
* Drug: Two anti-pseudomonal antibiotics


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Subject has received mechanical ventilation for at least 48h at the time of the randomisation Acute Physiology and Chronic Health Evaluation (APACHE) of 8 to 30, inclusive, within 24h prior to randomization Presence of new or progressive infiltrate on chest X-ray Presence of clinical criteria consistent with VABP High probability of VABP caused by Pseudomonas aeriginosa Key Exclusion Criteria: Known or suspected community-acquired bacterial pneumonia or viral, fungal, or parasitic pneumonia Known hypersensitivity or contra-indications to beta-lactam antibiotics, aminoglycosides, quinolones, colistin, or subjects with a clinically significant history of anaphylactic reaction Severe liver or renal impairment Women who are pregnant or nursing, or who are of chilbearing potential and unwilling to use acceptable method of birth control

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Murepavadin<br>Murepavadin IV + one anti-pseudomonal antibiotic | Drug: Murepavadin<br>* Murepavadin IV every 8 hours + 1 anti-pseudomonal antibiotic (Piperacillin-tazobactam, ceftazidine, cefepime, meropenem, amikacin, ciprofoxacin, levofloxacin, colistin)<br>|
| Active Comparator: Two anti-pseudomonal antibiotics<br>Association of 2 anti-pseudomonal antibiotics | Drug: Two anti-pseudomonal antibiotics<br>* Piperacillin-tazobactam, ceftazidine, cefepime, meropenem, amikacin, ciprofoxacin, levofloxacin, colistin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical cure rate |  | 21-24 days after start of study treatment |