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

Study Overview
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Brief Summary
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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.

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

Conditions
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Impetigo, Folliculitis, Secondarily Infected Eczema, Minor Soft Tissue Infections

Intervention / Treatment
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* Drug: Retapamulin (Altabax)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 9 Months
Maximum Age: 98 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Retapamulin ointment 1%<br> | Drug: Retapamulin (Altabax)<br>* Retapamulin ointment, applied topically twice daily for five days<br>* Other names: Altabax;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 to 8 days after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | baseline to 6 to 8 days after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Eczema, Atopic dermatitis, Infection, Impetigo, Folliculitis