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

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

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

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