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

NCT00684177 | Completed Phase 3 Results

• 1 other identifier: TOC110977
• Study Type: interventional
• Target: 508
• Locations: 5 countries
• Sites: 54

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.

Conditions

Skin Infections, Bacterial

Keywords

infection; retapamulin; secondarily-infected traumatic lesions; placebo

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Clinical Success and Failure at Follow-up (7-9 Days Post Therapy) for the Primary Efficacy Population

  "Clinical Success" at follow-up was defined as "Resolution of clinically meaningful signs and symptoms of infection recorded at baseline including a pus/exudate Skin Infection Rating Scale (SIRS) score of "0". Clinical response at follow-up was classified as "Clinical Failure" for all other cases. The SIRS consists of seven items (pus/exudates, crusting, erythema/inflammation, tissue warmth, tissue edema, itching and pain). Each item has a score ranging from 0 to 6 (0=absent, 6=severe). The SIRS total score was calculated as the sum of the scores of all 7 SIRS items.

  Days 12-14

Secondary Outcomes (5)

• 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

  Days 12-14

• Number of Participants With Microbiological Success and Failure at Follow-up (7-9 Days Post Therapy)

  Days 12-14

• Number of Participants With the Indicated Clinical Outcome at End of Therapy (2-4 Days Post Therapy)

  Days 7-9

• Number of Baseline Pathogens With the Indicated Microbiological Outcome at End of Therapy (2-4 Days Post Therapy)

  Days 7-9

• Number of Participants With Therapeutic Success and Failure at Follow-up (7-9 Days Post Therapy)

  Follow-up (Days 12-14)

Study Arms (2)

Retapamulin Ointment, 1%

EXPERIMENTAL

Drug: Retapamulin Ointment, 1%

Placebo Ointment

PLACEBO COMPARATOR

Drug: Placebo ointment

Interventions

Retapamulin Ointment, 1% DRUG

Provided as approximately 10 grams of an off-white smooth ointment in collapsible aluminum tubes with reverse taper puncture tip caps.

Also known as: Retapamulin Ointment, 1%

Retapamulin Ointment, 1%

Placebo ointment DRUG

Provided as approximately 10 grams of an off-white smooth ointment in collapsible aluminum tubes with reverse taper puncture tip caps.

Placebo Ointment

Eligibility Criteria

• Age: 2 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (54)

GSK Investigational Site

Tucson, Arizona, 85705, United States

Location

GSK Investigational Site

Anaheim, California, 92804, United States

Location

GSK Investigational Site

Fresno, California, 93710, United States

Location

GSK Investigational Site

Irvine, California, 90620, United States

Location

GSK Investigational Site

Los Angeles, California, 90048, United States

Location

GSK Investigational Site

Sacramento, California, 95825, United States

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GSK Investigational Site

Colorado Springs, Colorado, 80904, United States

Location

GSK Investigational Site

Deerfield Beach, Florida, 33441, United States

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GSK Investigational Site

Hollywood, Florida, 33023, United States

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GSK Investigational Site

Miami, Florida, 33144, United States

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GSK Investigational Site

Miami, Florida, 33155, United States

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GSK Investigational Site

Orlando, Florida, 32712, United States

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GSK Investigational Site

Panama City, Florida, 32401, United States

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GSK Investigational Site

Tampa, Florida, 33606, United States

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GSK Investigational Site

Vero Beach, Florida, 32960, United States

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GSK Investigational Site

West Palm Beach, Florida, 33401, United States

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GSK Investigational Site

Arlington Heights, Illinois, 60005, United States

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GSK Investigational Site

Kansas City, Kansas, 66160, United States

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GSK Investigational Site

New Orleans, Louisiana, 70112, United States

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GSK Investigational Site

Butte, Montana, 59701, United States

Location

GSK Investigational Site

Teaneck, New Jersey, 07666, United States

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GSK Investigational Site

Brooklyn, New York, 11218, United States

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GSK Investigational Site

Brooklyn, New York, 11229, United States

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GSK Investigational Site

East Syracuse, New York, 13057, United States

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GSK Investigational Site

Johnson City, New York, 13790, United States

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GSK Investigational Site

Cincinnati, Ohio, 45246, United States

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GSK Investigational Site

Norristown, Pennsylvania, 19401, United States

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GSK Investigational Site

Uniontown, Pennsylvania, 15401, United States

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GSK Investigational Site

Greenville, South Carolina, 29615, United States

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GSK Investigational Site

Houston, Texas, 77036, United States

Location

GSK Investigational Site

Bountiful, Utah, 84010, United States

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GSK Investigational Site

Vienna, Virginia, 22180, United States

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GSK Investigational Site

Buenos Aires, Buenos Aires, CP1431FWO, Argentina

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GSK Investigational Site

Chivilocoy, Buenos Aires, 6620, Argentina

Location

GSK Investigational Site

Loma Hermosa, Buenos Aires, 1657, Argentina

Location

GSK Investigational Site

Buenos Aires, C1180AAX, Argentina

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GSK Investigational Site

Curitiba, Paraná, 80240-280, Brazil

Location

GSK Investigational Site

Curitiba/Paraná, Paraná, 80810-050, Brazil

Location

GSK Investigational Site

Passo Fundo, Rio Grande do Sul, 99010-080, Brazil

Location

GSK Investigational Site

Bangalore, 560002, India

Location

GSK Investigational Site

Lucknow, 226003, India

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GSK Investigational Site

Pune, India

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GSK Investigational Site

Vadodara, 390001, India

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GSK Investigational Site

Wardha, 442102, India

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GSK Investigational Site

Belville, 7530, South Africa

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GSK Investigational Site

Benoni, 1501, South Africa

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GSK Investigational Site

Cape Town, 7572, South Africa

Location

GSK Investigational Site

Cape Town, South Africa

Location

GSK Investigational Site

Hatfield, 83, South Africa

Location

GSK Investigational Site

Lynnwood, 81, South Africa

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GSK Investigational Site

Midrand, 1, South Africa

Location

GSK Investigational Site

Newton, 6045, South Africa

Location

GSK Investigational Site

Welkom, 9460, South Africa

Location

GSK Investigational Site

Worcester, 6850, South Africa

Location

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Cellulitis; Infections

Condition Hierarchy (Ancestors)

Skin Diseases, Infectious; Suppuration; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2008
• First Posted: May 26, 2008
• Study Start: May 1, 2008
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: November 23, 2016
• Results First Posted: August 4, 2010

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

US (32); IN (5); BR (3); ZA (10); AR (4)