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

Impetigo Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01126268
• Other study ID #: HSC-MS-09-0650
• Status: Completed
• Phase: Phase 4
• First received: April 19, 2010
• Last updated: January 20, 2016
• Start date: April 2010
• Est. completion date: November 2012

Study information

• Verified date: January 2016
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 9 Months to 98 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Communicable Diseases
• Folliculitis
• Impetigo
• Infection
• Minor Soft Tissue Infections
• Secondarily Infected Eczema
• Soft Tissue Infections

Intervention

Drug:
• Retapamulin (Altabax)
Retapamulin ointment, applied topically twice daily for five days

Locations

Country	Name	City	State
United States	Houston Medical Center Building	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

References & Publications (1)

Bohaty BR, Choi S, Cai C, Hebert AA. Clinical and bacteriological efficacy of twice daily topical retapamulin ointment 1% in the management of impetigo and other uncomplicated superficial skin infections. International Journal of Women's Dermatology 1: 13

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes