At a glance
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A Phase 1, Prospective, Multi-center, Open-label Study to Assess the Plasma Pharmacokinetics and Lung Penetration of Intravenous (IV) Ceftolozane/Tazobactam in Critically Ill Patients
In Brief
A Phase 1 clinical trial evaluating Ceftolozane/Tazobactam - Multiple Doses and Ceftolozane/Tazobactam - Single Dose for Critically Ill and Pneumonia. Completed, enrolled 37 participants.
Detailed Summary
The purpose of this study is to evaluate the pharmacokinetics and lung penetration of intravenous Ceftolozane/tazobactam in critically ill participants.
Study Details
Timeline
Interventions
4-6 doses of ceftolozane/tazobactam every 8 hours as a 60-minute intravenous infusion as follows: * Participants with CLCR \> 50 mL/min will receive 4-6 doses of 3 g ceftolozane/tazobactam every 8 hours * Participants with CLCR 30 - 50 mL/min will receive 4-6 doses of 1.5 g ceftolozane/tazobactam every 8 hours * Participants with CLCR 15 - 29 mL/min will receive 6 doses of 750 mg ceftolozane/tazobactam every 8 hours
Single dose of ceftolozane/tazobactam, 3 g, as a 60-minute intravenous infusion