Retapamulin Versus Placebo in Secondarily-Infected Traumatic Lesions (SITL)

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00684177
• Date of registration: 22/05/2008
• Primary sponsor: GlaxoSmithKline
• Public title: Retapamulin Versus Placebo in Secondarily-Infected Traumatic Lesions (SITL)
• Scientific title: A Randomized, Double-Blind, Multicenter, Placebo-controlled, Phase III Superiority Study to Assess the Safety and Efficacy of Topical Retapamulin Ointment, 1%, Versus Placebo Ointment Applied Twice Daily for 5 Days in the Treatment of Adult and Pediatric Subjects With SITL
• Date of first enrolment: May 2008
• Target sample size: 508
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00684177
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Countries of recruitment

Argentina, Brazil, India, Peru, Philippines, South Africa, United States

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion criteria

Inclusion criteria:

- subject is aged 2 months or older

- subject has secondarily-infected traumatic lesion (laceration, sutured wound or
abrasion)

- negative urine pregnancy test

- subject has total skin infection rating scale score of at least 8, including
pus/exudate score of at least 3

- subject and/or parent/legal guardian is willing and able to comply with protocol

- subject or parent/legal guardian has given written informed consent or assent as
applicable

Exclusion criteria:

- previous hypersensitivity to pleuromutilin

- secondarily-infected animal/human bite or puncture wound

- subject has an abscess

- chronic ulcerative lesion

- underlying skin disease

- systemic signs and symptoms of infection

- infection not appropriately treated with topical antibiotic

- infection requires surgical intervention prior to or during study

- subject received systemic antibacterial or steroid, or topical therapeutic agent
within 24 hours of entry into study

- serious underlying disease

- subject pregnant, breast feeding or planning a pregnancy, or unacceptable method of
contraception

- other investigational drug within 30 days of study entry

- subject previously enrolled in this study



Age minimum: 2 Months
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Secondarily-infected Abrasions

Secondarily-infected Lacerations

Secondarily-infected Sutured Wounds

Secondarily-infected Traumatic Lesions

Skin Infections, Bacterial

Intervention(s)

Drug: Placebo ointment

Drug: Retapamulin Ointment, 1%

Primary Outcome(s)

Number of Participants With Clinical Success and Failure at Follow-up (7-9 Days Post Therapy) for the Primary Efficacy Population [Time Frame: Days 12-14]

Secondary Outcome(s)

Number of Baseline Pathogens With the Indicated Microbiological Outcome at End of Therapy (2-4 Days Post Therapy) [Time Frame: Days 7-9]

Number of Participants With Clinical Success and Failure at Follow-up (7-9 Days Post Therapy) for the Intent-to-Treat Bacteriology (ITTB) Subset of the Primary Efficacy Population [Time Frame: Days 12-14]

Number of Participants With Microbiological Success and Failure at Follow-up (7-9 Days Post Therapy) [Time Frame: Days 12-14]

Number of Participants With the Indicated Clinical Outcome at End of Therapy (2-4 Days Post Therapy) [Time Frame: Days 7-9]

Number of Participants With Therapeutic Success and Failure at Follow-up (7-9 Days Post Therapy) [Time Frame: Follow-up (Days 12-14)]

Secondary ID(s)

TOC110977

Source(s) of Monetary Support

Please refer to primary and secondary sponsors