CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 38 enrolled
Drug / intervention
Retapamulin (Altabax)drug
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.

Search/NCT01126268
NCT01126268Phase 4Completed

Twice Daily Altabax Application for the Treatment of Uncomplicated Soft Tissue Infection

The University of Texas Health Science Center, Houston·interventional·Posted May 19, 2010·Updated Feb 17, 2016

In Brief

A Phase 4 clinical trial evaluating Retapamulin (Altabax) for Impetigo and 3 related conditions. Completed, enrolled 38 participants across 1 site.

Detailed Summary

The purpose of this study is to document the clinical and bacteriological efficacy of retapamulin in the treatment of subjects with bacterial infections, including impetigo, folliculitis, and minor soft tissue infections including secondarily infected eczema presumed to be caused by methicillin resistant Staph aureus. Male and female patients ages 9 months to 98 years will be recruited from a university based dermatology clinic. Upon enrollment, wound cultures will be collected, and then subjects will apply topical retapamulin twice daily for five days. The primary endpoint will be resolution of methicillin-resistant Staphylococcus aureus (MRSA) infection based on clinical presentation and physical exam, as well as bacteriological efficacy based on culture results. It is anticipated that approximately 75 patients will be enrolled, with expectation that approximately 50 of these patients will have MRSA infections.

Study Details

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

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 19, 2010
Enrollment StartApr 1, 2010
Primary CompletionNov 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 16.1 years ago

Interventions

Retapamulin (Altabax)drug

Retapamulin ointment, applied topically twice daily for five days