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

The University of Texas System (UT)

Status and phase

Completed

Phase 4

Conditions

Secondarily Infected Eczema

Minor Soft Tissue Infections

Impetigo

Folliculitis

Treatments

Drug: Retapamulin (Altabax)

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01126268

HSC-MS-09-0650

Details and patient eligibility

About

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.

Enrollment

38 patients

Sex

All

Ages

9 months to 98 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female patients from 9 months of age up to 98 years of age.
Clinical diagnosis of impetigo, folliculitis, or minor soft tissue infection including secondarily infected eczema presumed to be caused by Staphylococcus aureus.
The patient, and if applicable the parent or guardian, is able to give informed consent
Females of child bearing potential have a negative urine pregnancy test.
Patient, and if applicable parent or guardian, are willing to and capable of complying with the study protocol.

Exclusion criteria

Subject who has used a topical antibacterial medication to the area being treated within the last 48 hours.
Subject who has been enrolled in a clinical trial within the last 30 days.
Subject with signs of systemic infection (such as fever), or with evidence of abscess or cellulitis at the site to be treated.
Subject has a bacterial skin infection which would not be appropriately treated by a topical antibiotic in the opinion of the investigator
Subjects who have taken oral antibiotics within the last 7 days.
Subjects with known sensitivity to the study medication.
The subject is pregnant or breastfeeding