Clinical trial NCT00684177: Retapamulin Versus Placebo in Secondarily-Infected Traumatic Lesions (SITL)
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Skin Infections, Bacterial
Keywords: infection
retapamulin
secondarily-infected traumatic lesions
placebo
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-05-26
Enrollment: 508
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of Study TOC110977 is to demonstrate clinical superiority of Retapamulin ointment, 1%, over placebo in patients with secondarily-infected traumatic lesions, which includes secondarily-infected lacerations, abrasions and sutured wounds. Subjects 2 months of age and older will be treated with topical retapamulin or placebo ointment twice daily for 5 days. The primary endpoint of this study is the clinical response at follow-up (Day 12-14; 7-9 days after the end of therapy) in the intent-to-treat clinical population.

Detailed description: This is a prospective, multicenter, double-blind, placebo-controlled parallel group study in subjects aged 2 months and older with SITL, including secondarily-infected lacerations, sutured wounds or abrasions. A laceration or sutured wound cannot exceed 10 cm in length with surrounding erythema not extending more than 2 cm from the edge of the lesion. Abrasions cannot exceed 100 cm2 in total area, or up to a maximum of 2% total body surface area for subjects \<18 years of age, with surrounding erythema not extending more than 2 cm from the edge of the abrasion.

There are four study visits occurring over a 12-14 day period. At the Baseline visit (Visit 1, Day 1), subjects will be randomized to receive retapamulin or placebo ointment in a 2:1 (retapamulin:placebo) ratio. The 2:1 randomization is included to minimize the number of subjects exposed to treatment with placebo. Both active treatment and placebo will be dosed topically twice daily (BID) for 5 days. All subjects will receive a telephone call from the investigator or appropriate designee appointed by the investigator on Day 2. The subject will be interviewed to determine if there is any evidence of worsening infection. Subjects who are thought to be worsening will be instructed to come in to the clinic for an assessment. Subjects will be monitored and clinically evaluated at the On-therapy (Days 3-4), End of Therapy (Days 7-9), and Follow-up (Days 12-14) visits.

Randomization will be center-based and performed using an appropriate Interactive Voice Response System (IVRS), an automated telephone system. The block size will remain confidential.

Subjects are considered to have completed the study if they meet all inclusion/exclusion criteria, are considered compliant with study medication, and attend all study visits as defined by the protocol.

Eligibility 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

Primary outcomes:
measure: Number of Participants With Clinical Success and Failure at Follow-up (7-9 Days Post Therapy) for the Primary Efficacy Population
timeFrame: Days 12-14
Secondary outcomes:
measure: 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
timeFrame: Days 12-14
measure: Number of Participants With Microbiological Success and Failure at Follow-up (7-9 Days Post Therapy)
timeFrame: Days 12-14
measure: Number of Participants With the Indicated Clinical Outcome at End of Therapy (2-4 Days Post Therapy)
timeFrame: Days 7-9
measure: Number of Baseline Pathogens With the Indicated Microbiological Outcome at End of Therapy (2-4 Days Post Therapy)
timeFrame: Days 7-9
measure: Number of Participants With Therapeutic Success and Failure at Follow-up (7-9 Days Post Therapy)
timeFrame: Follow-up (Days 12-14)
Other outcomes:
Locations:
city: Tucson
country: United States
facility: GSK Investigational Site
state: Arizona
city: Anaheim
country: United States
facility: GSK Investigational Site
state: California
city: Fresno
country: United States
facility: GSK Investigational Site
state: California
city: Irvine
country: United States
facility: GSK Investigational Site
state: California
city: Los Angeles
country: United States
facility: GSK Investigational Site
state: California
city: Sacramento
country: United States
facility: GSK Investigational Site
state: California
city: Colorado Springs
country: United States
facility: GSK Investigational Site
state: Colorado
city: Deerfield Beach
country: United States
facility: GSK Investigational Site
state: Florida
city: Hollywood
country: United States
facility: GSK Investigational Site
state: Florida
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Orlando
country: United States
facility: GSK Investigational Site
state: Florida
city: Panama City
country: United States
facility: GSK Investigational Site
state: Florida
city: Tampa
country: United States
facility: GSK Investigational Site
state: Florida
city: Vero Beach
country: United States
facility: GSK Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: GSK Investigational Site
state: Florida
city: Arlington Heights
country: United States
facility: GSK Investigational Site
state: Illinois
city: Kansas City
country: United States
facility: GSK Investigational Site
state: Kansas
city: New Orleans
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Butte
country: United States
facility: GSK Investigational Site
state: Montana
city: Teaneck
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Brooklyn
country: United States
facility: GSK Investigational Site
state: New York
city: Brooklyn
country: United States
facility: GSK Investigational Site
state: New York
city: East Syracuse
country: United States
facility: GSK Investigational Site
state: New York
city: Johnson City
country: United States
facility: GSK Investigational Site
state: New York
city: Cincinnati
country: United States
facility: GSK Investigational Site
state: Ohio
city: Norristown
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Uniontown
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Greenville
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: Bountiful
country: United States
facility: GSK Investigational Site
state: Utah
city: Vienna
country: United States
facility: GSK Investigational Site
state: Virginia
city: Chivilocoy
country: Argentina
facility: GSK Investigational Site
state: Buenos Aires
city: Loma Hermosa
country: Argentina
facility: GSK Investigational Site
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: GSK Investigational Site
city: Buenos Aires
country: Argentina
facility: GSK Investigational Site
city: Curitiba/Paraná
country: Brazil
facility: GSK Investigational Site
state: Paraná
city: Curitiba
country: Brazil
facility: GSK Investigational Site
state: Paraná
city: Passo Fundo
country: Brazil
facility: GSK Investigational Site
state: Rio Grande Do Sul
city: Bangalore
country: India
facility: GSK Investigational Site
city: Lucknow
country: India
facility: GSK Investigational Site
city: Pune
country: India
facility: GSK Investigational Site
city: Vadodara
country: India
facility: GSK Investigational Site
city: Wardha
country: India
facility: GSK Investigational Site
city: Belville
country: South Africa
facility: GSK Investigational Site
city: Benoni
country: South Africa
facility: GSK Investigational Site
city: Cape Town
country: South Africa
facility: GSK Investigational Site
city: Cape Town
country: South Africa
facility: GSK Investigational Site
city: Hatfield
country: South Africa
facility: GSK Investigational Site
city: Lynnwood
country: South Africa
facility: GSK Investigational Site
city: Midrand
country: South Africa
facility: GSK Investigational Site
city: Newton
country: South Africa
facility: GSK Investigational Site
city: Welkom
country: South Africa
facility: GSK Investigational Site
city: Worcester
country: South Africa
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: