CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 43 enrolled
Drug / intervention
Ceftolozane/Tazobactam 1000/500 mg +4 moredrug
Likely dose
Ceftolozane/Tazobactam 1000/500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02266706
NCT02266706Phase 1Completed
CompareCT.gov

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

Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)·interventional·Posted Oct 17, 2014·Updated Sep 11, 2019

In Brief

A Phase 1 clinical trial evaluating Ceftolozane/Tazobactam 1000/500 mg, Ceftolozane/Tazobactam 30/15 mg/kg, and 3 other interventions for Proven or Suspected Gram-negative Bacterial Infection and Peri-operative Prophylaxis. Completed, enrolled 43 participants.

Detailed Summary

The purpose of this study was to assess the pharmacokinetics, safety, and tolerability of a single intravenous dose of ceftolozane/tazobactam (MK-7625A) in pediatric participants. In each of the 6 age cohorts, an interim analysis of pharmacokinetics (PK) and safety data was conducted after approximately 3 participants had received the initially proposed dose. The interim analysis was to determine whether the initial dose was appropriate based on pre-defined criteria. If data from the interim analysis demonstrated that the initially proposed dose met the above criteria, enrollment was to continue with the same dose administered to approximately 3 additional participants of the same age range. However, if the interim analysis demonstrated that a new optimized dose was required, the new dose was to be administered to approximately 3 additional participants of the same age range.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProven or Suspected Gram-negative Bacterial Infection, Peri-operative Prophylaxis
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 17, 2014
Enrollment StartSep 17, 2014
Primary CompletionJun 8, 2017
Study CompletionJun 15, 2017
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 11.7 years ago

Interventions

Ceftolozane/Tazobactam 1000/500 mgdrug

A fixed dose combination (FDC) of 1000 mg ceftolozane and 500 mg tazobactam as a 60 minute infusion.

Ceftolozane/Tazobactam 30/15 mg/kgdrug

A FDC of 30 mg/kg of ceftolozane and 15 mg/kg of tazobactam as a 60 minute infusion.

Ceftolozane/Tazobactam 20/10 mg/kgdrug

A FDC of 20 mg/kg of ceftolozane and 10 mg/kg of tazobactam as a 60 minute infusion.

Ceftolozane/Tazobactam 18/9 mg/kgdrug

A FDC of 18 mg/kg of ceftolozane and 9 mg/kg of tazobactam as a 60 minute infusion.

Ceftolozane/Tazobactam 12/6 mg/kgdrug

A FDC of 12 mg/kg of ceftolozane and 6 mg/kg of tazobactam as a 60 minute infusion.