
    safety data review
  
['pneumonia']
['murepavadin', 'two anti-pseudomonal antibiotics']

        Key Inclusion Criteria:

          -  Subject has received mechanical ventilation for at least 48h at the time of the
             randomisation

          -  Acute Physiology and Chronic Health Evaluation (APACHE) of 8 to 30, inclusive, within
             24h prior to randomization

          -  Presence of new or progressive infiltrate on chest X-ray

          -  Presence of clinical criteria consistent with VABP

          -  High probability of VABP caused by Pseudomonas aeriginosa

        Key Exclusion Criteria:

          -  Known or suspected community-acquired bacterial pneumonia or viral, fungal, or
             parasitic pneumonia

          -  Known hypersensitivity or contra-indications to beta-lactam antibiotics,
             aminoglycosides, quinolones, colistin, or subjects with a clinically significant
             history of anaphylactic reaction

          -  Severe liver or renal impairment

          -  Women who are pregnant or nursing, or who are of chilbearing potential and unwilling
             to use acceptable method of birth control
      