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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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.

Detailed Summary:
Sponsor: The University of Texas Health Science Center, Houston

Current Primary Outcome: Number of Participants Whose Wound Cultures Were Positive for MRSA and Who Were Determined to be a Clinical Success at the Follow-up Visit [ Time Frame: 6 to 8 days after treatment ]

Clinical success is defined as no further signs or symptoms of infection present, including erythema, purulence, crusting, edema, warmth and pain.


Original Primary Outcome: The percentage of study participants whose wound cultures were positive for MRSA who are determined to be a clinical success at the follow-up visit. [ Time Frame: Study day 6 to 7 ]

The primary outcome measure is the percentage of study participants whose wound cultures were positive for MRSA who are determined to be a clinical success at the follow-up visit. Clinical success is defined as no further signs or symptoms of infection present including erythema, purulence, crusting, edema, warmth and pain.


Current Secondary Outcome:

  • Clinical Response at Follow up as Assessed by a Rating Scale [ Time Frame: 6 to 8 days after treatment ]
    Clinical response was based on clinical evaluation by the investigator at the follow-up visit using a predefined scale with the following categories: (1) clinical success, (2) clinical improvement, (3) no change, (4) clinical failure, and (5) unable to determine. Patients who were designated as clinical success as defined in number 1 above were considered a true "clinical success" while all others were considered a "clinical failure." Patients were classified with an outcome of "unable to determine" if they missed their follow-up visit or refused clinical examination.
  • Microbiologic Response at Follow up as Assessed by a Rating Scale [ Time Frame: 6 to 8 days after treatment ]
    Microbiological response was determined by the investigator at the follow-up visit using the following microbiological outcomes: (1) microbological eradication, (2) presumed microbiological eradication, (3) presumed microbiological improvement, (4) microbiological persistence, (5) presumed microbiological persistence, (6) unable to determine, (7) new pathogen, and (8) colonization. Patients who were designated microbiological eradication, presumed microbiological eradication, presumed microbiological improvement, or colonization as defined in numbers 1, 2, 3, and 8 above were considered a "microbiological success" while all others were considered "microbiological failure."
  • Number of Participants Who Were a Therapeutic Success [ Time Frame: 6 to 8 days after treatment ]
    Therapeutic response was determined from the clinical response and the microbiological response. Patients who qualified as both a "clinical success" and a "microbiological success" were deemed a "therapeutic success," and all others were deemed "therapeutic failures."
  • Erythema (Sign and Symptom of Infection) at Baseline [ Time Frame: baseline ]
    Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.
  • Erythema (Sign and Symptom of Infection) at Follow up [ Time Frame: 6 to 8 days after treatment ]
    Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.
  • Purulence (Sign and Symptom of Infection) at Baseline [ Time Frame: baseline ]
    Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.
  • Purulence (Sign and Symptom of Infection) at Follow up [ Time Frame: 6 to 8 days after treatment ]
    Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.
  • Crusting (Sign and Symptom of Infection) at Baseline [ Time Frame: baseline ]
    Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.
  • Crusting (Sign and Symptom of Infection) at Follow up [ Time Frame: 6 to 8 days after treatment ]
    Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.
  • Tissue Edema (Sign and Symptom of Infection) at Baseline [ Time Frame: baseline ]
    Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.
  • Tissue Edema (Sign and Symptom of Infection) at Follow up [ Time Frame: 6 to 8 days after treatment ]
    Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.
  • Tissue Warmth (Sign and Symptom of Infection) at Baseline [ Time Frame: baseline ]
    Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.
  • Tissue Warmth (Sign and Symptom of Infection) at Follow up [ Time Frame: 6 to 8 days after treatment ]
    Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.
  • Pain (Sign and Symptom of Infection) at Baseline [ Time Frame: baseline ]
    Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.
  • Pain (Sign and Symptom of Infection) at Follow up [ Time Frame: 6 to 8 days after treatment ]
    Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.
  • Wound Size at Baseline [ Time&nb

    Original Secondary Outcome:

    Information By: The University of Texas Health Science Center, Houston

    Dates:
    Date Received: April 19, 2010
    Date Started: April 2010
    Date Completion:
    Last Updated: January 20, 2016
    Last Verified: January 2016