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



Status:Recruiting
Conditions:Pneumonia
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:4/28/2018
Start Date:September 23, 2014
End Date:June 19, 2018
Contact:Toll Free Number
Phone:1-888-577-8839

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A Prospective, Randomized, Double-Blind, Multicenter, Phase 3 Study to Assess the Safety and Efficacy of Intravenous Ceftolozane/Tazobactam Compared With Meropenem in Adult Patients With Ventilated Nosocomial Pneumonia

This is a phase 3, multicenter, prospective, randomized study of intravenous (IV)
ceftolozane/tazobactam vs. IV meropenem in the treatment of adult participants with either
ventilator-associated bacterial pneumonia (VABP) or ventilated hospital-acquired bacterial
pneumonia (HABP).


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.
We found this trial at
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