Peri-operative Prophylaxis Clinical Trial
Official title:
A Phase 1, Non-comparative, Open-label Study to Characterize the Pharmacokinetics of a Single Intravenous Dose of Ceftolozane/Tazobactam in Pediatric Patients Receiving Standard of Care Antibiotic Therapy for Proven or Suspected Gram-negative Infection or for Peri-operative Prophylaxis
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.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02266706 -
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)
|
Phase 1 |