Safety and Efficacy Study of Ceftolozane/Tazobactam to Treat Ventilated Nosocomial Pneumonia (MK-7625A-008)

Key Inclusion Criteria:

- Adult participants diagnosed with either VABP or ventilated HABP requiring IV
antibiotic therapy;

- Intubated and on mechanical ventilation at the time of randomization;

- New or progressive infiltrate on chest radiography consistent with pneumonia;

- Presence of clinical criteria consistent with a diagnosis of ventilated nosocomial
pneumonia.

Key Exclusion Criteria:

- History of moderate or severe hypersensitivity reactions to beta-lactam antibiotics;

- Prior non-study antibiotics for > 24 hours;

- Gram stain of lower respiratory tract specimen showing only gram positive bacteria;

- Active immunosuppression;

- End-stage renal disease or requirement for dialysis;

- Expected survival < 72 hours;

- Severe confounding respiratory condition (i.e., chest trauma with paradoxical
respiration);

- Known or suspected community-acquired bacterial pneumonia.

- Anticipated concomitant use of any of the following medications during the course of
study therapy: valproic acid or divalproex sodium. Anticipated concomitant use of
serotonin re-uptake inhibitors, tricyclic antidepressants, or serotonin 5-HT1 receptor
agonists (triptans), meperidine, or buspirone during the course of linezolid
treatment.

- Receipt of a monoamine oxidase inhibitor within 14 days prior to the first dose of
study drug or anticipated concomitant use during the course of linezolid therapy.