CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 82 enrolled
Drug / intervention
Daptomycin +1 moredrug
Likely dose
Daptomycin 7 mg/kgfrom 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/NCT01728376
NCT01728376Phase 4Completed
CompareCT.gov

A Comparative Evaluation of the Safety and Efficacy of Daptomycin Versus Standard of Care in Pediatric Subjects One - Seventeen Years of Age With Bacteremia Caused by Staphylococcus Aureus.

Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)·interventional·Posted Nov 19, 2012·Updated Aug 28, 2018

In Brief

A Phase 4 clinical trial evaluating Daptomycin and Comparator for Bacteremia. Completed, enrolled 82 participants.

Detailed Summary

The intent of this study is to describe the safety and efficacy of daptomycin versus standard of care (SOC) in pediatric participants aged 1-17 years with bacteremia caused by Staphylococcus aureus (S. aureus).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBacteremia
Countries--
Collaborators--

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedNov 19, 2012
Enrollment StartNov 29, 2012
Primary CompletionJan 20, 2016
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 13.6 years ago

Interventions

Daptomycindrug

Intravenous daptomycin given at 7 mg/kg (ages 12-17 years); 9 mg/kg (ages 7-11 years); 12 mg/kg (ages 1-6 years) infused once daily, intravenously, over 30 or 60 minutes. Participants may be switched to oral therapy following completion of IV study drug administration provided they showed clear clinical improvement and the pathogen was susceptible to an oral agent.

Comparatordrug

Vancomycin, Semi-synthetic penicillin, First-generation cephalosporins, Clindamycin: administered per standard of care. Participants may be switched to oral therapy following completion of IV study drug administration provided they showed clear clinical improvement and the pathogen was susceptible to an oral agent.