Trial record 2 of 4 for:
ALTABAX | United States, Texas
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:
The University of Texas Health Science Center, Houston
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
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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
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:
|
Eczema Folliculitis Impetigo Soft Tissue Infections Dermatitis Skin Diseases Skin Diseases, Eczematous Hair Diseases |
Staphylococcal Skin Infections Staphylococcal Infections Gram-Positive Bacterial Infections Bacterial Infections Streptococcal Infections Skin Diseases, Bacterial Skin Diseases, Infectious Infection |
ClinicalTrials.gov processed this record on May 21, 2013