Pivotal Study in Nosocomial Pneumonia Suspected or Confirmed to be Due to Pseudomonas (PRISM-UDR)

This is an interventional treatment trial for Pneumonia Read More

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