
    safety data review
  
['pneumonia']
['murepavadin', 'one anti-pseudomonal antibiotic']

        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
      