Clinical trial NCT02387372
Conditions: Critically Ill Pneumonia
Sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Start date: 2015-02-05; Completion date: 2017-06-16
Enrollment: 37 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the pharmacokinetics and lung penetration of intravenous Ceftolozane/tazobactam in critically ill participants.

Detailed description:
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).

Arms: arm 1: Participants with proven or suspected pneumonia, undergoing mechanical ventilation will receive 4-6 doses of ceftolozane/tazobactam every 8 hours as a 60-minute intravenous infusion as follows:

* Those with Creatinine clearance (CLCR) \> 50 mL/min will receive 4-6 doses of 3 g ceftolozane/tazobactam every 8 hours
* Those with CLCR 30 - 50 mL/min will receive 4-6 doses of 1.5 g ceftolozane/tazobactam every 8 hours
* Those with CLCR 15 - 29 mL/min will receive 6 doses of 750 mg ceftolozane/tazobactam every 8 hours arm 2: Critically ill participants with CLCR ≥180 mL/min (as calculated by the Cockcroft-Gault equation) will receive a single dose of ceftolozane/tazobactam, 3 g, as a 60-minute intravenous infusion.
Interventions: intervention 1: Ceftolozane/Tazobactam - Multiple Doses intervention 2: Ceftolozane/Tazobactam - Single Dose
Intervention descriptions: intervention 1: 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 intervention 2: Single dose of ceftolozane/tazobactam, 3 g, as a 60-minute intravenous infusion

Protocol documents:
Prot_SAP_000.pdf: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Official Protocol Title: A Phase 1, Prospective, Multicenter, Open-label Study to Assess 
the Plasma Pharmacokinetics and Lung Penetration of Intravenous 
(IV) Ceftolozane/tazobactam in Critically Ill Patients 
NCT number: 
NCT02387372 
Document Date: 
04-November-2015 


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