Pneumonia Clinical Trial
Official title:
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
The purpose of this study is to evaluate the pharmacokinetics and lung penetration of intravenous Ceftolozane/tazobactam in critically ill participants.
This is a Phase 1, prospective, multicenter, non-comparative, open-label study to
characterize the plasma pharmacokinetics and intrapulmonary penetration of
ceftolozane/tazobactam in two groups of participants.
Group 1: approximately 25 ventilated participants with suspected or proven pneumonia
receiving concurrent standard antibiotic therapy. Within Group 1, efforts will be made to
enroll approximately 5 participants with a CLCR ≥ 150 mL/min (as calculated by the
Cockcroft-Gault equation).
Group 2: 8-10 critically ill participants with CLCR ≥180 mL/min (as calculated by the
Cockcroft-Gault equation).
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