Pivotal Study in VAP Suspected or Confirmed to be Due to Pseudomonas Aeruginosa
Pivotal Study in VAP Suspected or Confirmed to be Due to Pseudomonas Aeruginosa
This is a phase 3, multicenter, open-label, randomized active-controlled, parallel group to
 investigate the efficacy, safety and tolerability, and pharmacokinetics of intravenous
 murepavadin combined with of one anti-pseudononas antibiotic with that of two
 anti-pseudomonas antibiotics in the treatment of ventilator-associated bacterial pneumonia
 (VABP) in adult subjects.
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