Skin Infections, BacterialPhase 3NCT00852540
Retapamulin Versus Linezolid in the Treatment of SITL and Impetigo Due to MRSA
A Phase 3 study testing Retpamulin Ointment, 1% and Linezolid in people with Skin Infections, Bacterial, run by Stiefel, a GSK Company at 53 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 months and older
- Conditions the study is for
- Skin Infections, Bacterial
- What is being tested?
- Retpamulin Ointment, 1% and Linezolid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 410 participants
- Where
- 53 sitesUnited States
- Study dates
- Apr 2009to Sep 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 21Show fewer
- 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)
Trial locations and contacts
53 sites in 1 country.
53 sites in 1 country
United States53 sites
GSK Investigational Site
Anniston, Alabama, 36207
GSK Investigational Site
Atlantis, Florida, 33462
GSK Investigational Site
Austin, Texas, 78734
GSK Investigational Site
Bakerfield, California, 93301
GSK Investigational Site
Bay Pines, Florida, 33744
GSK Investigational Site
Bell Gardens, California, 90201
GSK Investigational Site
Bentonville, Arkansas, 72172
GSK Investigational Site
Birmingham, Alabama, 35235
GSK Investigational Site
Brooklyn, New York, 11203
GSK Investigational Site
Butte, Montana, 59701
GSK Investigational Site
Carlisle, Ohio, 45005
GSK Investigational Site
Charlottesville, Virginia, 22902
GSK Investigational Site
Colorado Springs, Colorado, 80909
GSK Investigational Site
Columbus, Georgia, 31904
GSK Investigational Site
Corvallis, Oregon, 97330
GSK Investigational Site
Dallas, Texas, 75204
GSK Investigational Site
Dallas, Texas, 75390-9113
GSK Investigational Site
Duncanville, Texas, 75116
GSK Investigational Site
Fort Lauderdale, Florida, 33306
GSK Investigational Site
Fort Lauderdale, Florida, 33308
GSK Investigational Site
Fort Worth, Texas, 76107
GSK Investigational Site
Grand Blanc, Michigan, 48439
GSK Investigational Site
Gresham, Oregon, 97030
GSK Investigational Site
Hazleton, Pennsylvania, 18201
GSK Investigational Site
Honolulu, Hawaii, 96813
GSK Investigational Site
Honolulu, Hawaii, 96814
GSK Investigational Site
Houston, Texas, 77030
GSK Investigational Site
Huntington Beach, California, 92647
GSK Investigational Site
Jackson, Mississippi, 39216-4505
GSK Investigational Site
Jonesboro, Arkansas, 72401
GSK Investigational Site
Layton, Utah, 84041
GSK Investigational Site
Long Beach, California, 90813
GSK Investigational Site
Louisville, Kentucky, 40217
GSK Investigational Site
Macon, Georgia, 31217
GSK Investigational Site
Miami, Florida, 33144
GSK Investigational Site
New Orleans, Louisiana, 70112
GSK Investigational Site
Omaha, Nebraska, 68114
GSK Investigational Site
Omaha, Nebraska, 68131
GSK Investigational Site
Overland Park, Kansas, 66215
GSK Investigational Site
Paragould, Arkansas, 72450
GSK Investigational Site
Pensacola, Florida, 32504
GSK Investigational Site
Pittsburgh, Pennsylvania, 15212
GSK Investigational Site
Portland, Oregon, 97210
GSK Investigational Site
Roseville, California, 95661
GSK Investigational Site
Sacramento, California, 92585
GSK Investigational Site
Savannah, Georgia, 31406
GSK Investigational Site
Seattle, Washington, 98101
GSK Investigational Site
South Bend, Indiana, 46601
GSK Investigational Site
St. Petersburg, Florida, 33710
GSK Investigational Site
Tulsa, Oklahoma, 74127
GSK Investigational Site
Vero Beach, Florida, 32960
GSK Investigational Site
Washington D.C., District of Columbia, 20037
GSK Investigational Site
West Palm Beach, Florida, 33401
About this study
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
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.
Read the 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
- Being tested
- Retpamulin Ointment, 1%, Linezolid
- Keywords
- impetigo, methicillin-resistant Staphylococcus aureus, linezolid, secondarily-infected traumatic lesion, uncomplicated skin infection, retapamulin
- Medical subject headings
- Cellulitis, Impetigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retpamulin Ointment, 1%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.
LinezolidDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Retapamulin | Experimental | Not described Receives: Drug: Retpamulin Ointment, 1% |
| Linezolid | Active comparator | Not described Receives: Drug: Linezolid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 7-9 days post-therapy; Day 12-14 for retapamulin and Day 17-19 for linezolid
Secondary outcomes (10)
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."
Measured: 7-9 days post-therapy; Day 12-14 for retapamulin and Day 17-19 for linezolid
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).
Measured: 7-9 days post-therapy; Day 12-14 for retapamulin and Day 17-19 for linezolid
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."
Measured: 7-9 days post-therapy; Day 12-14 for retapamulin and Day 17-19 for linezolid
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.
Measured: 2-4 days post-therapy; Day 7-9 for retapamulin and Day 12-14 for linezolid
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.
Measured: 2-4 days post-therapy; Day 7-9 for retapamulin and Day 12-14 for linezolid
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.
Measured: 2-4 days post-therapy; Day 7-9 for retapamulin and Day 12-14 for linezolid
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.
Measured: 2-4 days post-therapy; Day 7-9 for retapamulin and Day 12-14 for linezolid
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.
Measured: 7-9 days post-therapy; Day 12-14 for retapamulin and Day 17-19 for linezolid
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.
Measured: Visits 1 (Day 1), 2 (Day 3-4), 3 (Day 7-9), 4 (Day 12-14), and 5 (Day 17-19)
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.
Measured: Visits 1 (Day 1), 2 (Day 3-4), 3 (Day 7-9), 4 (Day 12-14), and 5 (Day 17-19)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2009 (estimated)
- Study startApr 2009
- Primary completionJul 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Skin Infections, BacterialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 410 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stiefel, a GSK Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00852540
- Sponsor's protocol ID
- 110978
- Status last verified
- Feb 2017
- First submitted
- 26 Feb 2009
- Last updated
- 27 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Publications
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.
PubMed 25396674
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00852540
- Acronym / sponsor ID
- 110978
- Conditions
- Skin Infections, Bacterial
- Keywords
- impetigo, methicillin-resistant Staphylococcus aureus, linezolid, secondarily-infected traumatic lesion, uncomplicated skin infection, retapamulin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 410 participants (actual)
- Lead sponsor
- Stiefel, a GSK CompanyIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- Apr 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 27 Feb 2009 (estimated)
- Results
- Posted 26 Aug 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retapamulin | Experimental | Drug: Retpamulin Ointment, 1% |
| Linezolid | Active comparator | Drug: Linezolid |
Who may qualify
- Ages
- 2 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (21 listed)
- previous hypersensitivity to pleuromutilins or oxazolidinones
- phenylketonuria or known hypersensitivity to aspartame
- secondarily-infected animal/human bite, or puncture wound
- abscess
- chronic ulcerative lesion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Retapamulin |
| LinezolidAdult 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. | Drug | Linezolid |
Primary outcome
Number of Participants Achieving Clinical Response at Follow-up Who Had Methicillin-resistant Staphlococcus Aureus (MRSA) as a Baseline Pathogen
Time frame: 7-9 days post-therapy; Day 12-14 for retapamulin and Day 17-19 for linezolid
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).
10 secondary outcomes
Number of Participants Achieving Microbiological Response (MR) at Follow-up (FU) Who Had MRSA as a Baseline Pathogen (BP)
Time frame: 7-9 days post-therapy; Day 12-14 for retapamulin and Day 17-19 for linezolid
Number of Participants With Clinical Response at Follow-up
Time frame: 7-9 days post-therapy; Day 12-14 for retapamulin and Day 17-19 for linezolid
Number of Participants Who Achieved Microbiological Response (MR) at Follow-up (FU) Who Had a Baseline Pathogen (BP)
Time frame: 7-9 days post-therapy; Day 12-14 for retapamulin and Day 17-19 for linezolid
Number of Participants With the Indicated Clinical Outcome at the End of Therapy Who Had MRSA as a Baseline Pathogen
Time frame: 2-4 days post-therapy; Day 7-9 for retapamulin and Day 12-14 for linezolid
Number of Participants With the Indicated Microbiological Outcome at the End of Therapy Who Had MRSA as a Baseline (BL) Pathogen
Time frame: 2-4 days post-therapy; Day 7-9 for retapamulin and Day 12-14 for linezolid
Number of Participants With the Indicated Clinical Outcome at the End of Therapy
Time frame: 2-4 days post-therapy; Day 7-9 for retapamulin and Day 12-14 for linezolid
Number of Baseline Pathogens With the Indicated Microbiological Outcome at the End of Therapy
Time frame: 2-4 days post-therapy; Day 7-9 for retapamulin and Day 12-14 for linezolid
Number of Participants With Therapeutic Response at Follow-up
Time frame: 7-9 days post-therapy; Day 12-14 for retapamulin and Day 17-19 for linezolid
Mean Scores on the Skin Infection Rating Scale 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)
Mean Wound Size 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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25396674Tanus 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.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Comparative Efficacy of Luliconazole and Bifonazole Combined With Itraconazole in Dermatophytosis
Tinea Corporis,Tinea Cruris,Tinea Faciei
Active, not recruitingPhase 2
A Study of Zasocitinib in Adults With Hidradenitis Suppurativa
Hidradenitis Suppurativa
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
53 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Retpamulin Ointment, 1% and Linezolid in people with Skin Infections, Bacterial, run by Stiefel, a GSK Company at 53 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Aug 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Achieving Clinical Response at Follow-up Who Had Methicillin-resistant Staphlococcus Aureus (MRSA) as a Baseline Pathogen (time frame: 7-9 days post-therapy; Day 12-14 for retapamulin and Day 17-19 for linezolid). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00852540, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2017.