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

This study is currently recruiting participants.
Verified February 2012 by The University of Texas Health Science Center, Houston
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: February 15, 2012
Last verified: February 2012
History of Changes

April 19, 2010
February 15, 2012
April 2010
April 2012   (final data collection date for primary outcome measure)
The percentage of study participants whose wound cultures were positive for MRSA who are determined to be a clinical success at the follow-up visit. [ Time Frame: Study day 6 to 7 ] [ Designated as safety issue: No ]
The primary outcome measure is the percentage of study participants whose wound cultures were positive for MRSA who are 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.
Same as current
Complete list of historical versions of study NCT01126268 on ClinicalTrials.gov Archive Site
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Twice Daily Altabax Application for the Treatment of Uncomplicated Soft Tissue Infection
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.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Impetigo
  • Folliculitis
  • Secondarily Infected Eczema
  • Minor Soft Tissue Infections
Drug: Retapamulin (Altabax)
Retapamulin ointment, applied topically twice daily for five days
Other Name: Altabax
Experimental: Retapamulin ointment 1%
Intervention: Drug: Retapamulin (Altabax)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
75
Not Provided
April 2012   (final data collection date for primary outcome measure)

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
Both
9 Months and older
No
Contact: Maria Lopez 713-500-8266 Maria.D.Lopez@uth.tmc.edu
United States
 
NCT01126268
ALT113516
No
Adelaide Hebert, The University of Texas Health Science Center, Houston
The University of Texas Health Science Center, Houston
GlaxoSmithKline
Principal Investigator: Adelaide A Hebert, M.D. University of Texas Health Science Center at Houston Department of Dermatology
The University of Texas Health Science Center, Houston
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP