Retapamulin Versus Linezolid in the Treatment of SITL and Impetigo Due to MRSA

NCT ID: NCT00852540

Last Updated: 2017-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 410 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2010-09-30

Brief Summary

The purpose of this study is to provide further evidence of the clinical and bacteriological efficacy of retapamulin in the treatment of subjects with SITL or impetigo due to MRSA. Subjects aged 2 months and older will be treated with either topical retapamulin for 5 days or oral linezolid for 10 days. The primary endpoint is the clinical response at follow-up (7-9 days after the end of therapy) in subjects who have a MRSA infection at baseline. The primary population is the per-protocol MRSA population. It is anticipated that approximately 500 subjects may be enrolled in order to obtain approximately 105 subjects who have a baseline MRSA infection.

Detailed Description

This is a prospective, randomized, double-blind, double dummy, multicenter, comparative study in subjects 2 months of age and older with SITL (including secondarily-infected lacerations, sutured wounds and abrasions) or impetigo (bullous and non-bullous) due to MRSA. 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. Subjects with impetigo can have up to 10 lesions and the infected lesion(s) must not be more than 100 cm2 in area (or up to a maximum of 2% total body surface area for subjects <18 years of age), must not require surgical intervention and must be able to be appropriately treated with a topical antibiotic.

There are five study visits occurring over a 17-19 day period. At the baseline visit (Visit 1, day 1), subjects will be randomized to receive retapamulin (plus oral placebo) or linezolid (plus placebo ointment) in a 2:1 ratio. Retapamulin is applied twice daily for 5 days, and linezolid is dosed, depending on subject age, either twice or three times daily for 10 days. The on-therapy, end of therapy and follow-up visits are staggered due to the difference in duration of the treatment regimens. Subjects will be monitored and clinically evaluated at all postbaseline visits.

Randomization will be center-based and stratified by age (<5 years, ≥5 to <12 years, ≥12 years), 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.

Conditions

Skin Infections, Bacterial

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Retapamulin

Group Type: EXPERIMENTAL

Retpamulin Ointment, 1%

Intervention Type: DRUG

Topical retapamulin (SB-275833) ointment, 1% (w/w), and placebo ointment, will be provided as approximately 10 grams of an off-white smooth ointment in collapsible aluminum tubes with reverse-taper puncture-tip caps. Retapamulin or placebo ointment will be applied twice daily for 5 days.

Linezolid

Group Type: ACTIVE_COMPARATOR

Linezolid

Intervention Type: DRUG

Adult and adolescent (=\>12 years of age) subjects will receive one 600mg linezolid tablet (overencapsulated), or one placebo capsule, twice daily for 10 days. Pediatric subjects aged 5-11 years will receive 10mg/kg body weight of a 100mg/5mL oral linezolid suspension, or placebo suspension, twice daily for 10 days. Pediatric subjects \<5 years of age will receive 10mg/kg of a 100mg/5mL oral linezolid suspension, or placebo suspension, three times daily for 10 days.

Interventions

Retpamulin Ointment, 1%

Topical retapamulin (SB-275833) ointment, 1% (w/w), and placebo ointment, will be provided as approximately 10 grams of an off-white smooth ointment in collapsible aluminum tubes with reverse-taper puncture-tip caps. Retapamulin or placebo ointment will be applied twice daily for 5 days.

Intervention Type: DRUG

Linezolid

Adult and adolescent (=\>12 years of age) subjects will receive one 600mg linezolid tablet (overencapsulated), or one placebo capsule, twice daily for 10 days. Pediatric subjects aged 5-11 years will receive 10mg/kg body weight of a 100mg/5mL oral linezolid suspension, or placebo suspension, twice daily for 10 days. Pediatric subjects \<5 years of age will receive 10mg/kg of a 100mg/5mL oral linezolid suspension, or placebo suspension, three times daily for 10 days.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 2 months of age or older
• diagnosis of secondarily-infected traumatic lesion (SITL) or impetigo (bullous or non-bullous)
• negative urine pregnancy test (females of childbearing potential)
• total skin infection rating scale (SIRS) score of at least 8, which must include a pus/exudate score of at least 3
• subject or parent/legal guardian willing and able to comply with protocol
• written informed, dated consent, and written assent (if applicable)

Exclusion Criteria

• previous hypersensitivity to pleuromutilins or oxazolidinones
• phenylketonuria or known hypersensitivity to aspartame
• secondarily-infected animal/human bite, or puncture wound
• abscess
• chronic ulcerative lesion
• underlying skin disease (eg, eczematous dermatitis) with secondary infection
• systemic signs and symptoms of infection
• skin infection not appropriate for treatment by a topical antibiotic (eg, extensive cellulitis, furunculosis)
• subject requires surgical intervention for infection prior to study or likely will during the study
• receipt of systemic antibacterial or steroid, or application of any topical therapeutic agent directly to wound within 24 hours of entry into the study
• subject currently receiving adrenergic agents
• subject currently receiving serotonergic agents
• history of pseudomembranous colitis
• known, pre-existing myelosuppression, history of myelosuppression with linezolid use, or receiving a medication that produces bone marrow suppression
• history of siezures
• history of severe renal failure and undergoing dialysis
• serious underlying disease that could be imminently life-threatening
• pregnant, breast feeding or planning a pregnancy, or not using accepted method of contraception (females of childbearing potential or <1 year post-menopausal)
• use of another investigational drug within 30 days prior to entry into this study
• previously enrolled in this study
• fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency (for subjects <12 years of age receiving linezolid suspension)

• Minimum Eligible Age: 2 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

Stiefel, a GSK Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Anniston, Alabama, United States

GSK Investigational Site

Birmingham, Alabama, United States

GSK Investigational Site

Bentonville, Arkansas, United States

GSK Investigational Site

Jonesboro, Arkansas, United States

GSK Investigational Site

Paragould, Arkansas, United States

GSK Investigational Site

Bakerfield, California, United States

GSK Investigational Site

Bell Gardens, California, United States

GSK Investigational Site

Huntington Beach, California, United States

GSK Investigational Site

Long Beach, California, United States

GSK Investigational Site

Roseville, California, United States

GSK Investigational Site

Sacramento, California, United States

GSK Investigational Site

Colorado Springs, Colorado, United States

GSK Investigational Site

Washington D.C., District of Columbia, United States

GSK Investigational Site

Atlantis, Florida, United States

GSK Investigational Site

Bay Pines, Florida, United States

GSK Investigational Site

Fort Lauderdale, Florida, United States

GSK Investigational Site

Fort Lauderdale, Florida, United States

GSK Investigational Site

Miami, Florida, United States

GSK Investigational Site

Pensacola, Florida, United States

GSK Investigational Site

St. Petersburg, Florida, United States

GSK Investigational Site

Vero Beach, Florida, United States

GSK Investigational Site

West Palm Beach, Florida, United States

GSK Investigational Site

Columbus, Georgia, United States

GSK Investigational Site

Macon, Georgia, United States

GSK Investigational Site

Savannah, Georgia, United States

GSK Investigational Site

Honolulu, Hawaii, United States

GSK Investigational Site

Honolulu, Hawaii, United States

GSK Investigational Site

South Bend, Indiana, United States

GSK Investigational Site

Overland Park, Kansas, United States

GSK Investigational Site

Louisville, Kentucky, United States

GSK Investigational Site

New Orleans, Louisiana, United States

GSK Investigational Site

Grand Blanc, Michigan, United States

GSK Investigational Site

Jackson, Mississippi, United States

GSK Investigational Site

Butte, Montana, United States

GSK Investigational Site

Omaha, Nebraska, United States

GSK Investigational Site

Omaha, Nebraska, United States

GSK Investigational Site

Brooklyn, New York, United States

GSK Investigational Site

Carlisle, Ohio, United States

GSK Investigational Site

Tulsa, Oklahoma, United States

GSK Investigational Site

Corvallis, Oregon, United States

GSK Investigational Site

Gresham, Oregon, United States

GSK Investigational Site

Portland, Oregon, United States

GSK Investigational Site

Hazleton, Pennsylvania, United States

GSK Investigational Site

Pittsburgh, Pennsylvania, United States

GSK Investigational Site

Austin, Texas, United States

GSK Investigational Site

Dallas, Texas, United States

GSK Investigational Site

Dallas, Texas, United States

GSK Investigational Site

Duncanville, Texas, United States

GSK Investigational Site

Fort Worth, Texas, United States

GSK Investigational Site

Houston, Texas, United States

GSK Investigational Site

Layton, Utah, United States

GSK Investigational Site

Charlottesville, Virginia, United States

GSK Investigational Site

Seattle, Washington, United States

Countries

United States

References

Tanus T, Scangarella-Oman NE, Dalessandro M, Li G, Breton JJ, Tomayko JF. A randomized, double-blind, comparative study to assess the safety and efficacy of topical retapamulin ointment 1% versus oral linezolid in the treatment of secondarily infected traumatic lesions and impetigo due to methicillin-resistant Staphylococcus aureus. Adv Skin Wound Care. 2014 Dec;27(12):548-59. doi: 10.1097/01.ASW.0000456631.20389.ae.

Reference Type: DERIVED

PMID: 25396674 (View on PubMed)

Study Documents

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

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

Other Identifiers

110978

Identifier Type: -

Identifier Source: org_study_id