Pivotal Study in Nosocomial Pneumonia Suspected or Confirmed to be Due to Pseudomonas

Study Overview
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Brief Summary
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This is a phase 3, multicenter, open-label, sponsor blinded, randomized active-controlled, parallel group to investigate the efficacy, safety and tolerability of intravenous murepavadin given with ertapenem versus an anti-pseudomonal β-lactam based antibiotic in the treatment of nosocomial pneumonia in adult subjects

Official Title
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A Multicenter, Open Label, Sponsor Blinded, Randomized, Active Controlled, Parallel Group, Pivotal Study to Evaluate the Efficacy, Safety, and Tolerability of Murepavadin Given With Ertapenem Versus an Anti-pseudomonal-β-lactam-based Antibiotic in Adult Subjects With Nosocomial 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: One anti-pseudomonal antibiotic


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 OR at least 2 of the following signs or symptoms presenting within 24 hours prior to randomization: New onset of cough or worsening of baseline cough and/or dyspnea, tachypnea and/or hypoxemia and/or new onset of sputum or suctioned respiratory secretion characterized by purulent appearance indicative of bacterial infection or a worsening in character of purulent appearance Acute Physiology and Chronic Health Evaluation (APACHE) of 8 to 25, inclusive, within 24h prior to randomization Presence of new or progressive infiltrate on chest X-ray Presence of clinical criteria consistent with Pneumonia Strong clinical suspicion of pneumonia due to P. aeruginosa Key Exclusion Criteria: Known or suspected community-acquired bacterial pneumonia or viral, fungal, or parasitic pneumonia known hypersensitivity to any component of ertapenem, meropenem or to other drugs in the same class or demonstrated anaphylactic reactions to beta-lactams or a history of allergic reactions to any of the penicillins, cephalosporins, or β-lactamase inhibitors Severe liver or renal impairment Expected survival < 72 hours Evidence from an available surveillance culture of co infection with ertapenem , meropenem or piperacillin tazobactam resistant Gram negative pathogen(s) Women who are pregnant or nursing

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Murepavadin<br>Murepavadin + ertapenem | Drug: Murepavadin<br>* Murepavadin + ertapenem<br>|
| Active Comparator: Anti-pseudomonal antibiotic<br>One anti-pseudomonal-β-lactam-based antibiotic (either meropenem or piperacillin-tazobactam) | Drug: One anti-pseudomonal antibiotic<br>* Either meropenem or piperacillin-tazobactam<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality rates |  | 28 days after start of study treatment |