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

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