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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Adelaide Hebert, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT01126268
First received: April 19, 2010
Last updated: January 20, 2016
Last verified: January 2016
  Purpose
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.

Condition Intervention Phase
Impetigo
Folliculitis
Secondarily Infected Eczema
Minor Soft Tissue Infections
Drug: Retapamulin (Altabax)
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Twice Daily Altabax Application for the Treatment of Uncomplicated Soft Tissue Infection

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Clinical success is defined as no further signs or symptoms of infection present, including erythema, purulence, crusting, edema, warmth and pain.


Secondary Outcome Measures:
  • Clinical Response at Follow up as Assessed by a Rating Scale [ Time Frame: 6 to 8 days after treatment ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.

  • Wound Size at Baseline [ Time Frame: baseline ] [ Designated as safety issue: No ]
    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.

  • Wound Size at Follow up [ Time Frame: 6 to 8 days after treatment ] [ Designated as safety issue: No ]
    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.

  • Number of Participants Reporting Any Adverse Event (AE) [ Time Frame: baseline to 6 to 8 days after treatment ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 38
Study Start Date: April 2010
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Retapamulin ointment 1% Drug: Retapamulin (Altabax)
Retapamulin ointment, applied topically twice daily for five days
Other Name: Altabax

  Eligibility

Ages Eligible for Study:   9 Months to 98 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01126268

Locations
United States, Texas
Houston Medical Center Building
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
GlaxoSmithKline
Investigators
Principal Investigator: Adelaide A Hebert, M.D. University of Texas Health Science Center at Houston Department of Dermatology
  More Information

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. International Journal of Women's Dermatology 1: 13-20, 2015.

Responsible Party: Adelaide Hebert, Professor of Dermatology and Pediatrics, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01126268     History of Changes
Other Study ID Numbers: HSC-MS-09-0650 
Study First Received: April 19, 2010
Results First Received: December 14, 2015
Last Updated: January 20, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by The University of Texas Health Science Center, Houston:
Eczema
Atopic dermatitis
Infection
Impetigo
Folliculitis

Additional relevant MeSH terms:
Communicable Diseases
Folliculitis
Impetigo
Infection
Soft Tissue Infections
Bacterial Infections
Gram-Positive Bacterial Infections
Hair Diseases
Skin Diseases
Skin Diseases, Bacterial
Skin Diseases, Infectious
Staphylococcal Infections
Staphylococcal Skin Infections
Streptococcal Infections

ClinicalTrials.gov processed this record on May 25, 2016