Clinical trial NCT01126268: Twice Daily Altabax Application for the Treatment of Uncomplicated Soft Tissue Infection
Official title: Twice Daily Altabax Application for the Treatment of Uncomplicated Soft Tissue Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Impetigo
Folliculitis
Secondarily Infected Eczema
Minor Soft Tissue Infections
Keywords: Eczema
Atopic dermatitis
Infection
Impetigo
Folliculitis
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2010-05-19
Enrollment: 38
Sex: ALL
Minimum age (years): 9
Maximum age (years): 98
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Number of Participants Whose Wound Cultures Were Positive for MRSA and Who Were Determined to be a Clinical Success at the Follow-up Visit
timeFrame: 6 to 8 days after treatment
Secondary outcomes:
measure: Clinical Response at Follow up as Assessed by a Rating Scale
timeFrame: 6 to 8 days after treatment
measure: Microbiologic Response at Follow up as Assessed by a Rating Scale
timeFrame: 6 to 8 days after treatment
measure: Number of Participants Who Were a Therapeutic Success
timeFrame: 6 to 8 days after treatment
measure: Erythema (Sign and Symptom of Infection) at Baseline
timeFrame: baseline
measure: Erythema (Sign and Symptom of Infection) at Follow up
timeFrame: 6 to 8 days after treatment
measure: Purulence (Sign and Symptom of Infection) at Baseline
timeFrame: baseline
measure: Purulence (Sign and Symptom of Infection) at Follow up
timeFrame: 6 to 8 days after treatment
measure: Crusting (Sign and Symptom of Infection) at Baseline
timeFrame: baseline
measure: Crusting (Sign and Symptom of Infection) at Follow up
timeFrame: 6 to 8 days after treatment
measure: Tissue Edema (Sign and Symptom of Infection) at Baseline
timeFrame: baseline
measure: Tissue Edema (Sign and Symptom of Infection) at Follow up
timeFrame: 6 to 8 days after treatment
measure: Tissue Warmth (Sign and Symptom of Infection) at Baseline
timeFrame: baseline
measure: Tissue Warmth (Sign and Symptom of Infection) at Follow up
timeFrame: 6 to 8 days after treatment
measure: Pain (Sign and Symptom of Infection) at Baseline
timeFrame: baseline
measure: Pain (Sign and Symptom of Infection) at Follow up
timeFrame: 6 to 8 days after treatment
measure: Wound Size at Baseline
timeFrame: baseline
measure: Wound Size at Follow up
timeFrame: 6 to 8 days after treatment
measure: Number of Participants Reporting Any Adverse Event (AE)
timeFrame: baseline to 6 to 8 days after treatment
Other outcomes:
Locations:
city: Houston
country: United States
facility: Houston Medical Center Building
state: Texas
Study officials:
affiliation: University of Texas Health Science Center at Houston Department of Dermatology
name: Adelaide A Hebert, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.