Last updated on April 2016

Pharmacokinetic and Safety Study of Ceftolozane/Tazobactam in Pediatric Participants Receiving Antibiotic Therapy for Proven or Suspected Gram-negative Infection or for Peri-operative Prophylaxis (MK-7625A-010)

Brief description of study

The purpose of this study is to assess the pharmacokinetics, safety, and tolerability of a single intravenous dose of ceftolozane/tazobactam in pediatric participants. Ceftolozane/tazobactam is a novel antibacterial consisting of ceftolozane, a unique antipseudomonal cephalosporin, with tazobactam, a well-established β-lactamase inhibitor. This is the first study investigating the use of ceftolozane/tazobactam in pediatric participants.

Detailed Study Description

Screening assessments will occur within 48 hours of study drug administration (Day 1). Baseline assessments will be performed following eligibility verification based on screening assessments. Participants will be monitored for safety 24 hours post study drug infusion. The site will contact the participant and/or parent (or appropriate legal representative) via telephone at Study Day 8 (± 2 days) for assessment of adverse events and concomitant medications and procedures. In each age cohort, an interim analysis of PK and safety data will be conducted after 3 participants have received the initially proposed dose. The interim analysis will determine whether this initial dose was appropriate based on pre-defined criteria. If data from the interim analysis demonstrates that the initially proposed dose meets the criteria above, enrollment will continue with the same dose administered to 3 additional participants. However, if the interim analysis demonstrates that a new optimized adjusted dose is required, the new adjusted dose will be administered to 3 new participants of the same age range. In subsequent cohorts, the initial dose is also subject to change based upon the results of the interim analysis in previous cohorts.

Clinical Study Identifier: NCT02725216

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