CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 104 enrolled
Drug / intervention
Daptomycin +1 moredrug
Likely dose
Daptomycin 4mg/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/NCT01549613
NCT01549613Phase 4Completed

Evaluation of Daptomycin for the Emergency Department Treatment of Complicated Skin and Skin Structure Infections

University of Cincinnati·interventional·Posted Mar 9, 2012·Updated Aug 1, 2014

In Brief

A Phase 4 clinical trial evaluating Daptomycin and Vancomycin for Cellulitis and Skin Infections. Completed, enrolled 104 participants across 1 site.

Detailed Summary

This is a prospective, randomized clinical trial comparing daptomycin to vancomycin in the Emergency Department (ED) treatment of complicated skin and skin structure infection in the Rapid Diagnosis and Treatment Center (RDTC). In brief, a convenience sample of patients who are admitted to the RDTC cellulitis protocol in the ED will be randomized to either vancomycin, which is currently an accepted care standard in the RDTC cellulitis protocol, or daptomycin, which is the experimental treatment in this study. The primary hypothesis is that daptomycin treatment is as efficacious as standard therapy in the treatment of ED cellulitis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 9, 2012
Enrollment StartMay 1, 2012
Primary CompletionJul 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 14.3 years ago

Interventions

Daptomycindrug

• Daptomycin will be given in a one-time dose of 4mg/kg in a one-time dose to be infused over 2 minutes at the initiation of patient therapy in the RDTC cellulitis protocol.

Vancomycindrug

• Vancomycin will be given in a dose of 15mg/kg at baseline and again at 12 hours to be infused over 1 to 2 hours.