NCT01126268

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 9 Months – 98 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Impetigo
• Folliculitis
• Secondarily Infected Eczema
• Minor Soft Tissue Infections

Interventions

Type	Name	Description
DRUG	Retapamulin (Altabax)	Retapamulin ointment, applied topically twice daily for five days

Timeline

• Start date: 2010-04-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2010-05-19
• Last updated: 2016-02-17
• Results posted: 2016-02-17

Locations

1 site across 1 country: United States