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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
38
Retapamulin ointment, applied topically twice daily for five days
Houston Medical Center Building
Houston, Texas, United States
Number of Participants Whose Wound Cultures Were Positive for MRSA and Who Were 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.
Time frame: 6 to 8 days after treatment
Clinical Response at Follow up as Assessed by a Rating Scale
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.
Time frame: 6 to 8 days after treatment
Microbiologic Response at Follow up as Assessed by a Rating Scale
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."
Time frame: 6 to 8 days after treatment
Number of Participants Who Were a Therapeutic Success
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."
Time frame: 6 to 8 days after treatment
Erythema (Sign and Symptom of Infection) at Baseline
Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.
Time frame: baseline
Erythema (Sign and Symptom of Infection) at Follow up
Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.
Time frame: 6 to 8 days after treatment
Purulence (Sign and Symptom of Infection) at Baseline
Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.
Time frame: baseline
Purulence (Sign and Symptom of Infection) at Follow up
Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.
Time frame: 6 to 8 days after treatment
Crusting (Sign and Symptom of Infection) at Baseline
Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.
Time frame: baseline
Crusting (Sign and Symptom of Infection) at Follow up
Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.
Time frame: 6 to 8 days after treatment
Tissue Edema (Sign and Symptom of Infection) at Baseline
Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.
Time frame: baseline
Tissue Edema (Sign and Symptom of Infection) at Follow up
Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.
Time frame: 6 to 8 days after treatment
Tissue Warmth (Sign and Symptom of Infection) at Baseline
Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.
Time frame: baseline
Tissue Warmth (Sign and Symptom of Infection) at Follow up
Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.
Time frame: 6 to 8 days after treatment
Pain (Sign and Symptom of Infection) at Baseline
Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.
Time frame: baseline
Pain (Sign and Symptom of Infection) at Follow up
Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.
Time frame: 6 to 8 days after treatment
Wound Size at Baseline
Wound size area was determined by measuring the greatest length of the wound in two perpendicular dimensions with a standard metric ruler. The two measurements were multiplied together to provide an estimate of the overall wound size. Surrounding erythema was not included in the measurement.
Time frame: baseline
Wound Size at Follow up
Wound size area was determined by measuring the greatest length of the wound in two perpendicular dimensions with a standard metric ruler. The two measurements were multiplied together to provide an estimate of the overall wound size. Surrounding erythema was not included in the measurement.
Time frame: 6 to 8 days after treatment
Number of Participants Reporting Any Adverse Event (AE)
AEs included burning at application site, upper respiratory infection, furuncle, cough, and a rash at a site other than the application site. See the Adverse Events section for more detailed information.
Time frame: baseline to 6 to 8 days after treatment
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