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

NCT01126268 | Completed Phase 4 Results

• 1 other identifier: HSC-MS-09-0650
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Impetigo; Folliculitis; Secondarily Infected Eczema; Minor Soft Tissue Infections

Keywords

Eczema; Atopic dermatitis; Infection; Impetigo; Folliculitis

Outcome Measures

Primary Outcomes (1)

• Number of Participants Whose Wound Cultures Were Positive for MRSA and Who Were 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.

  6 to 8 days after treatment

Secondary Outcomes (18)

• Clinical Response at Follow up as Assessed by a Rating Scale

  6 to 8 days after treatment

• Microbiologic Response at Follow up as Assessed by a Rating Scale

  6 to 8 days after treatment

• Number of Participants Who Were a Therapeutic Success

  6 to 8 days after treatment

• Erythema (Sign and Symptom of Infection) at Baseline

  baseline

• Erythema (Sign and Symptom of Infection) at Follow up

  6 to 8 days after treatment

Study Arms (1)

Retapamulin ointment 1%

EXPERIMENTAL

Drug: Retapamulin (Altabax)

Interventions

Retapamulin (Altabax) DRUG

Retapamulin ointment, applied topically twice daily for five days

Also known as: Altabax

Retapamulin ointment 1%

Eligibility Criteria

• Age: 9 Months - 98 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Houston Medical Center Building

Houston, Texas, 77030, United States

Location

Related Publications (1)

• 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.

  PMID: 28491950 RESULT

MeSH Terms

Conditions

Impetigo; Folliculitis; Eczema; Dermatitis, Atopic; Infections

Interventions

retapamulin

Condition Hierarchy (Ancestors)

Staphylococcal Skin Infections; Staphylococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Skin Diseases, Bacterial; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Hair Diseases; Dermatitis; Skin Diseases, Eczematous; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Dr. Adelaide A Hebert
• Organization: The University of Texas Health Science Center at Houston

Adelaide.A.Hebert@uth.tmc.edu

(713) 500-8339

Study Officials

• Adelaide A Hebert, M.D.

  University of Texas Health Science Center at Houston Department of Dermatology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Dermatology and Pediatrics

Study Record Dates

• First Submitted: April 19, 2010
• First Posted: May 19, 2010
• Study Start: April 1, 2010
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: February 17, 2016
• Results First Posted: February 17, 2016

Record last verified: 2016-01

Locations

US (1)