Twice Daily Altabax Application for the Treatment of Uncomplicated Soft Tissue Infection
Condition: Impetigo; Folliculitis; Secondarily Infected Eczema; Minor Soft Tissue Infections
MeSH terms: Infections; Communicable Diseases; Soft Tissue Infections; Impetigo; Eczema; Folliculitis
Intervention: Retapamulin (Altabax)
Intervention description: Retapamulin ointment, applied topically twice daily for five days
Intervention MeSH terms: Retapamulin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 38.0
Sex: All
Minimum age: 9 Months
Maximum age: 98 Years
Healthy volunteers: No
Keywords: Eczema; Atopic dermatitis; Infection; Impetigo; Folliculitis

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.
    

Eligibility criteria:

        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