Study of Intravenous Ceftolozane/Tazobactam Compared to Piperacillin/Tazobactam in Ventilator-Associated Pneumonia

• Status: Terminated
• Trial end date: 2013-12-08
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 3, multicenter, prospective, randomized, open-label, study to compare the safety and efficacy of intravenous (IV) ceftolozane/tazobactam with that of IV piperacillin/tazobactam in the treatment of ventilator-associated pneumonia (VAP) in adult participants .

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cubist Pharmaceuticals LLC
• Treatments: Ceftolozane; Ceftolozane, tazobactam drug combination; Cephalosporins; Penicillanic Acid; Piperacillin; Piperacillin, Tazobactam Drug Combination; Tazobactam

Criteria

Key Inclusion Criteria:

• Participant has received mechanical ventilation for > 48 hours

• Acute Physiology and Chronic Health Evaluation (APACHE) II score of 11-35

• Presence of a new or progressive infiltrate on chest x-ray

• Presence of clinical criteria consistent with VAP

Key Exclusion Criteria:

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

• Known end stage renal disease or requirement for dialysis