At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 396 enrolled
Drug / intervention
Daptomycin +1 moredrug
Likely dose
Not stated in 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.
An Evaluation of the Safety, Efficacy and Pharmacokinetics of Daptomycin in Pediatric Subjects Aged One to Seventeen Years With Complicated Skin and Skin Structure Infections Caused by Gram-Positive Pathogens
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)·interventional·Posted Jul 9, 2008·Updated Sep 5, 2018
In Brief
A Phase 4 clinical trial evaluating Daptomycin and Standard of Care (SOC) for Skin Diseases, Infectious. Completed, enrolled 396 participants across 30 sites in 3 countries.
Detailed Summary
This is a multi-center, evaluator-blinded, randomized, comparative study designed to assess the safety, efficacy, and pharmacokinetics (PK) of daptomycin in pediatric subjects ages 1 to 17 years, inclusive, with complicated skin and skin structure infections (cSSSI) caused by Gram-positive pathogens.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSkin Diseases, Infectious
CountriesIndia, Panama, United States
Collaborators--
Timeline
Phase 4CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 2008
Enrollment StartJul 2008
Primary CompletionOct 2013
TodayJul 2026
First PostedJul 9, 2008
Enrollment StartJul 23, 2008
Primary CompletionOct 11, 2013
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 18.0 years ago
Interventions
Daptomycindrug
Standard of Care (SOC)drug