Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Trial record 2 of 4 for:    ALTABAX | United States, Texas

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by The University of Texas Health Science Center, Houston.
Recruitment status was  Recruiting
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
  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: Allocation: Non-Randomized
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:
  • 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.


Estimated Enrollment: 75
Study Start Date: April 2010
Estimated Primary Completion Date: April 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 and older
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

Contacts
Contact: Maria Lopez 713-500-8266 Maria.D.Lopez@uth.tmc.edu

Locations
United States, Texas
Houston Medical Center Building Recruiting
Houston, Texas, United States, 77030
Contact: Maria Lopez    713-500-8266    Maria.D.Lopez@uth.tmc.edu   
Principal Investigator: Adelaide A Hebert, M.D.         
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

No publications provided

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: ALT113516
Study First Received: April 19, 2010
Last Updated: February 15, 2012
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 November 25, 2014