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

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 Overview

• Status: Completed
• Conditions: Folliculitis; Impetigo; Secondarily Infected Eczema; Minor Soft Tissue Infections
• Intervention / Treatment: Drug: Retapamulin (Altabax)

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Houston Medical Center Building

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 94 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Retapamulin ointment 1%	Drug: Retapamulin (Altabax); Retapamulin ointment, applied topically twice daily for five days; Other Names: Altabax

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: GlaxoSmithKline
• Investigators: Principal Investigator: Adelaide A Hebert, M.D., University of Texas Health Science Center at Houston Department of Dermatology

Publications and helpful links

General Publications

• 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. Int J Womens Dermatol. 2015 Mar 2;1(1):13-20. doi: 10.1016/j.ijwd.2014.12.002. eCollection 2015 Feb.

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: April 19, 2010
• First Submitted That Met QC Criteria: May 18, 2010
• First Posted (Estimate): May 19, 2010

Study Record Updates

• Last Update Posted (Estimate): February 17, 2016
• Last Update Submitted That Met QC Criteria: January 20, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Infection; Atopic dermatitis; Eczema; Impetigo; Folliculitis
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Disease Attributes; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Skin Diseases, Infectious; Staphylococcal Infections; Skin Diseases, Bacterial; Dermatitis; Skin Diseases, Eczematous; Hair Diseases; Staphylococcal Skin Infections; Infections; Communicable Diseases; Eczema; Soft Tissue Infections; Folliculitis; Impetigo; Anti-Infective Agents; Anti-Bacterial Agents; Retapamulin
• Other Study ID Numbers: HSC-MS-09-0650