search
Back to results

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

Primary Purpose

Skin Infections, Bacterial

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Retpamulin Ointment, 1%
Linezolid
Sponsored by
Stiefel, a GSK Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Skin Infections, Bacterial focused on measuring impetigo, methicillin-resistant Staphylococcus aureus, linezolid, secondarily-infected traumatic lesion, uncomplicated skin infection, retapamulin

Eligibility Criteria

2 Months - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Retapamulin

Linezolid

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants Achieving Clinical Response at Follow-up Who Had Methicillin-resistant Staphlococcus Aureus (MRSA) as a Baseline Pathogen
Follow-up is defined as 7-9 days post-therapy: Day 12-14 for retapamulin; Day 17-19 for linezolid. Clinical success at follow-up was defined as the resolution of clinically meaningful signs and symptoms of infection recorded at baseline, including a pus/exudate skin infection rating scale (SIRS) score of "0." The SIRS is used by the investigator to evaluate infected lesions. Scores on the SIRS range from 0 (absent) to 6 (severe).

Secondary Outcome Measures

Number of Participants Achieving Microbiological Response (MR) at Follow-up (FU) Who Had MRSA as a Baseline Pathogen (BP)
MR was defined as microbiological success if, (1) for participants (par.) whose clinical outcome at end of therapy (EOT) was "clinical success (CS)/improvement," the BP was eradicated/presumed to be eradicated at EOT, or the BP was present at EOT and absent at FU, or the BP was eradicated/presumed to be eradicated at EOT, or the BP was present at EOT and par. was a "CS" such that no culture was obtained due to lack of culturable material secondary to adequate clinical response; or (2) a pathogen not previously identified at baseline was isolated at FU in a par. identified at FU as a "CS."
Number of Participants With Clinical Response at Follow-up
Follow-up is defined as 7-9 days post-therapy: Day 12-14 for retapamulin; Day 17-19 for linezolid. Clinical success at follow-up was defined as the resolution of clinically meaningful signs and symptoms of infection recorded at baseline, including a pus/exudate skin infection rating scale (SIRS) score of "0." The SIRS is used by the investigator to evaluate infected lesions. Scores on the SIRS range from 0 (absent) to 6 (severe).
Number of Participants Who Achieved Microbiological Response (MR) at Follow-up (FU) Who Had a Baseline Pathogen (BP)
MR was defined as microbiological success if, (1) for participants (par.) whose clinical outcome at end of therapy (EOT) was "clinical success (CS)/improvement," the BP was eradicated/presumed to be eradicated at EOT, or the BP was present at EOT and absent at FU, or the BP was eradicated/presumed to be eradicated at EOT, or the BP was present at EOT and par. was a "CS" such that no culture was obtained due to lack of culturable material secondary to adequate clinical response; or (2) a pathogen not previously identified at baseline was isolated at FU in a par. identified at FU as a "CS."
Number of Participants With the Indicated Clinical Outcome at the End of Therapy Who Had MRSA as a Baseline Pathogen
Clinical improvement is defined as improvement of signs/symptoms of infection recorded at baseline (BL) to such an extent that no further antimicrobial therapy is necessary. Clinical failure (CF) is defined as insufficient improvement/deterioration of signs/symptoms of the infection recorded at BL, such that additional antibiotic therapy is required. Unable to determine (UTD) is defined as refusal to consent to a clinical examination, lost to follow-up. Participants who are "CF"/"Unable to Determine" at end of therapy are considered such at follow-up as well.
Number of Participants With the Indicated Microbiological Outcome at the End of Therapy Who Had MRSA as a Baseline (BL) Pathogen
Eradication is the elimination of BL pathogens. Presumed eradication and presumed improvement are clinical outcomes of success or improvement, respectively, such that no culture was obtained due to lack of culturable material, secondary to adequate clinical response, and is documented in the electronic Case Report Form. Persistence is defined as BL pathogens still being present. Presumed persistence is defined as a participant that is a clinical failure with no obtained culture. "Unable to determine" was used if no determination of BL pathogen microbiological response could be made.
Number of Participants With the Indicated Clinical Outcome at the End of Therapy
Clinical improvement is defined as improvement of signs/symptoms of infection recorded at baseline (BL) to such an extent that no further antimicrobial therapy is necessary. Clinical failure (CF) is defined as insufficient improvement/deterioration of signs/symptoms of the infection recorded at BL, such that additional antibiotic therapy is required. Unable to determine (UTD) is defined as refusal to consent to a clinical examination, lost to follow-up. Participants who are "CF"/"Unable to Determine" at end of therapy are considered such at follow-up as well.
Number of Baseline Pathogens With the Indicated Microbiological Outcome at the End of Therapy
Eradication is the elimination of BL pathogens. Presumed eradication and presumed improvement are clinical outcomes of success or improvement, respectively, such that no culture was obtained due to lack of culturable material, secondary to adequate clinical response, and is documented in the electronic Case Report Form. Persistence is defined as BL pathogens still being present. Presumed persistence is defined as a participant that is a clinical failure with no obtained culture. "Unable to determine" was used if no determination of BL pathogen microbiological response could be made.
Number of Participants With Therapeutic Response at Follow-up
Therapeutic response is defined as the combined clinical and microbiological response. Therapeutic response iss a measure of the overall efficacy response, and a therapeutic success refers to participants who had been deemed both a "clinical success" and a "microbiological success." All other combinations (other than "clinical success" + "microbiological success") were deemed failures for therapeutic response.
Mean Scores on the Skin Infection Rating Scale at Visits 1, 2, 3, 4, and 5
The investigator evaluated skin infections by grading the infected lesion for exudate (a fluid that leaks out of blood vessels into surrounding tissue)/pus, crusting, erythema (redness of the skin)/ inflammation (E/I), tissue warmth, tissue edema (swelling), itching, and pain, according to the Skin Infection Rating Scale. All parameters were graded on a scale of 0 (absent) to 6 (severe). The total score is calculated by summing the individual scores from the 7 parameters; the total score ranges from 0 to 42.
Mean Wound Size at Visits 1, 2, 3, 4, and 5
Lesion sized was measured in centimeters squared at Visits 1, 2, 3, 4, and 5.

Full Information

First Posted
February 26, 2009
Last Updated
February 23, 2017
Sponsor
Stiefel, a GSK Company
Collaborators
GlaxoSmithKline
search

1. Study Identification

Unique Protocol Identification Number
NCT00852540
Brief Title
Retapamulin Versus Linezolid in the Treatment of SITL and Impetigo Due to MRSA
Official Title
A Randomized, Double-Blind, Double Dummy, Comparative, Multicenter 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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stiefel, a GSK Company
Collaborators
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Infections, Bacterial
Keywords
impetigo, methicillin-resistant Staphylococcus aureus, linezolid, secondarily-infected traumatic lesion, uncomplicated skin infection, retapamulin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
410 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Retapamulin
Arm Type
Experimental
Arm Title
Linezolid
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Retpamulin Ointment, 1%
Intervention Description
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
Intervention Name(s)
Linezolid
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants Achieving Clinical Response at Follow-up Who Had Methicillin-resistant Staphlococcus Aureus (MRSA) as a Baseline Pathogen
Description
Follow-up is defined as 7-9 days post-therapy: Day 12-14 for retapamulin; Day 17-19 for linezolid. Clinical success at follow-up was defined as the resolution of clinically meaningful signs and symptoms of infection recorded at baseline, including a pus/exudate skin infection rating scale (SIRS) score of "0." The SIRS is used by the investigator to evaluate infected lesions. Scores on the SIRS range from 0 (absent) to 6 (severe).
Time Frame
7-9 days post-therapy; Day 12-14 for retapamulin and Day 17-19 for linezolid
Secondary Outcome Measure Information:
Title
Number of Participants Achieving Microbiological Response (MR) at Follow-up (FU) Who Had MRSA as a Baseline Pathogen (BP)
Description
MR was defined as microbiological success if, (1) for participants (par.) whose clinical outcome at end of therapy (EOT) was "clinical success (CS)/improvement," the BP was eradicated/presumed to be eradicated at EOT, or the BP was present at EOT and absent at FU, or the BP was eradicated/presumed to be eradicated at EOT, or the BP was present at EOT and par. was a "CS" such that no culture was obtained due to lack of culturable material secondary to adequate clinical response; or (2) a pathogen not previously identified at baseline was isolated at FU in a par. identified at FU as a "CS."
Time Frame
7-9 days post-therapy; Day 12-14 for retapamulin and Day 17-19 for linezolid
Title
Number of Participants With Clinical Response at Follow-up
Description
Follow-up is defined as 7-9 days post-therapy: Day 12-14 for retapamulin; Day 17-19 for linezolid. Clinical success at follow-up was defined as the resolution of clinically meaningful signs and symptoms of infection recorded at baseline, including a pus/exudate skin infection rating scale (SIRS) score of "0." The SIRS is used by the investigator to evaluate infected lesions. Scores on the SIRS range from 0 (absent) to 6 (severe).
Time Frame
7-9 days post-therapy; Day 12-14 for retapamulin and Day 17-19 for linezolid
Title
Number of Participants Who Achieved Microbiological Response (MR) at Follow-up (FU) Who Had a Baseline Pathogen (BP)
Description
MR was defined as microbiological success if, (1) for participants (par.) whose clinical outcome at end of therapy (EOT) was "clinical success (CS)/improvement," the BP was eradicated/presumed to be eradicated at EOT, or the BP was present at EOT and absent at FU, or the BP was eradicated/presumed to be eradicated at EOT, or the BP was present at EOT and par. was a "CS" such that no culture was obtained due to lack of culturable material secondary to adequate clinical response; or (2) a pathogen not previously identified at baseline was isolated at FU in a par. identified at FU as a "CS."
Time Frame
7-9 days post-therapy; Day 12-14 for retapamulin and Day 17-19 for linezolid
Title
Number of Participants With the Indicated Clinical Outcome at the End of Therapy Who Had MRSA as a Baseline Pathogen
Description
Clinical improvement is defined as improvement of signs/symptoms of infection recorded at baseline (BL) to such an extent that no further antimicrobial therapy is necessary. Clinical failure (CF) is defined as insufficient improvement/deterioration of signs/symptoms of the infection recorded at BL, such that additional antibiotic therapy is required. Unable to determine (UTD) is defined as refusal to consent to a clinical examination, lost to follow-up. Participants who are "CF"/"Unable to Determine" at end of therapy are considered such at follow-up as well.
Time Frame
2-4 days post-therapy; Day 7-9 for retapamulin and Day 12-14 for linezolid
Title
Number of Participants With the Indicated Microbiological Outcome at the End of Therapy Who Had MRSA as a Baseline (BL) Pathogen
Description
Eradication is the elimination of BL pathogens. Presumed eradication and presumed improvement are clinical outcomes of success or improvement, respectively, such that no culture was obtained due to lack of culturable material, secondary to adequate clinical response, and is documented in the electronic Case Report Form. Persistence is defined as BL pathogens still being present. Presumed persistence is defined as a participant that is a clinical failure with no obtained culture. "Unable to determine" was used if no determination of BL pathogen microbiological response could be made.
Time Frame
2-4 days post-therapy; Day 7-9 for retapamulin and Day 12-14 for linezolid
Title
Number of Participants With the Indicated Clinical Outcome at the End of Therapy
Description
Clinical improvement is defined as improvement of signs/symptoms of infection recorded at baseline (BL) to such an extent that no further antimicrobial therapy is necessary. Clinical failure (CF) is defined as insufficient improvement/deterioration of signs/symptoms of the infection recorded at BL, such that additional antibiotic therapy is required. Unable to determine (UTD) is defined as refusal to consent to a clinical examination, lost to follow-up. Participants who are "CF"/"Unable to Determine" at end of therapy are considered such at follow-up as well.
Time Frame
2-4 days post-therapy; Day 7-9 for retapamulin and Day 12-14 for linezolid
Title
Number of Baseline Pathogens With the Indicated Microbiological Outcome at the End of Therapy
Description
Eradication is the elimination of BL pathogens. Presumed eradication and presumed improvement are clinical outcomes of success or improvement, respectively, such that no culture was obtained due to lack of culturable material, secondary to adequate clinical response, and is documented in the electronic Case Report Form. Persistence is defined as BL pathogens still being present. Presumed persistence is defined as a participant that is a clinical failure with no obtained culture. "Unable to determine" was used if no determination of BL pathogen microbiological response could be made.
Time Frame
2-4 days post-therapy; Day 7-9 for retapamulin and Day 12-14 for linezolid
Title
Number of Participants With Therapeutic Response at Follow-up
Description
Therapeutic response is defined as the combined clinical and microbiological response. Therapeutic response iss a measure of the overall efficacy response, and a therapeutic success refers to participants who had been deemed both a "clinical success" and a "microbiological success." All other combinations (other than "clinical success" + "microbiological success") were deemed failures for therapeutic response.
Time Frame
7-9 days post-therapy; Day 12-14 for retapamulin and Day 17-19 for linezolid
Title
Mean Scores on the Skin Infection Rating Scale at Visits 1, 2, 3, 4, and 5
Description
The investigator evaluated skin infections by grading the infected lesion for exudate (a fluid that leaks out of blood vessels into surrounding tissue)/pus, crusting, erythema (redness of the skin)/ inflammation (E/I), tissue warmth, tissue edema (swelling), itching, and pain, according to the Skin Infection Rating Scale. All parameters were graded on a scale of 0 (absent) to 6 (severe). The total score is calculated by summing the individual scores from the 7 parameters; the total score ranges from 0 to 42.
Time Frame
Visits 1 (Day 1), 2 (Day 3-4), 3 (Day 7-9), 4 (Day 12-14), and 5 (Day 17-19)
Title
Mean Wound Size at Visits 1, 2, 3, 4, and 5
Description
Lesion sized was measured in centimeters squared at Visits 1, 2, 3, 4, and 5.
Time Frame
Visits 1 (Day 1), 2 (Day 3-4), 3 (Day 7-9), 4 (Day 12-14), and 5 (Day 17-19)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Months
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
GSK Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35235
Country
United States
Facility Name
GSK Investigational Site
City
Bentonville
State/Province
Arkansas
ZIP/Postal Code
72172
Country
United States
Facility Name
GSK Investigational Site
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
GSK Investigational Site
City
Paragould
State/Province
Arkansas
ZIP/Postal Code
72450
Country
United States
Facility Name
GSK Investigational Site
City
Bakerfield
State/Province
California
ZIP/Postal Code
93301
Country
United States
Facility Name
GSK Investigational Site
City
Bell Gardens
State/Province
California
ZIP/Postal Code
90201
Country
United States
Facility Name
GSK Investigational Site
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
GSK Investigational Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
Facility Name
GSK Investigational Site
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
GSK Investigational Site
City
Sacramento
State/Province
California
ZIP/Postal Code
92585
Country
United States
Facility Name
GSK Investigational Site
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
GSK Investigational Site
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
GSK Investigational Site
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Facility Name
GSK Investigational Site
City
Bay Pines
State/Province
Florida
ZIP/Postal Code
33744
Country
United States
Facility Name
GSK Investigational Site
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
GSK Investigational Site
City
Ft. Lauderdale
State/Province
Florida
ZIP/Postal Code
33306
Country
United States
Facility Name
GSK Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
GSK Investigational Site
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32504
Country
United States
Facility Name
GSK Investigational Site
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33710
Country
United States
Facility Name
GSK Investigational Site
City
Vero Beach
State/Province
Florida
ZIP/Postal Code
32960
Country
United States
Facility Name
GSK Investigational Site
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
GSK Investigational Site
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
GSK Investigational Site
City
Macon
State/Province
Georgia
ZIP/Postal Code
31217
Country
United States
Facility Name
GSK Investigational Site
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
GSK Investigational Site
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
GSK Investigational Site
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96814
Country
United States
Facility Name
GSK Investigational Site
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
GSK Investigational Site
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66215
Country
United States
Facility Name
GSK Investigational Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Facility Name
GSK Investigational Site
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
GSK Investigational Site
City
Grand Blanc
State/Province
Michigan
ZIP/Postal Code
48439
Country
United States
Facility Name
GSK Investigational Site
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216-4505
Country
United States
Facility Name
GSK Investigational Site
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
GSK Investigational Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
GSK Investigational Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
GSK Investigational Site
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
GSK Investigational Site
City
Carlisle
State/Province
Ohio
ZIP/Postal Code
45005
Country
United States
Facility Name
GSK Investigational Site
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74127
Country
United States
Facility Name
GSK Investigational Site
City
Corvallis
State/Province
Oregon
ZIP/Postal Code
97330
Country
United States
Facility Name
GSK Investigational Site
City
Gresham
State/Province
Oregon
ZIP/Postal Code
97030
Country
United States
Facility Name
GSK Investigational Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
GSK Investigational Site
City
Hazleton
State/Province
Pennsylvania
ZIP/Postal Code
18201
Country
United States
Facility Name
GSK Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
GSK Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78734
Country
United States
Facility Name
GSK Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75204
Country
United States
Facility Name
GSK Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-9113
Country
United States
Facility Name
GSK Investigational Site
City
Duncanville
State/Province
Texas
ZIP/Postal Code
75116
Country
United States
Facility Name
GSK Investigational Site
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76107
Country
United States
Facility Name
GSK Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
GSK Investigational Site
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
Facility Name
GSK Investigational Site
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22902
Country
United States
Facility Name
GSK Investigational Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Citations:
PubMed Identifier
25396674
Citation
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.
Results Reference
derived
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
110978
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
110978
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
110978
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
110978
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
110978
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
110978
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
110978
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

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

We'll reach out to this number within 24 hrs