Skin Infections, BacterialPhase 3NCT00684177
Retapamulin Versus Placebo in Secondarily-Infected Traumatic Lesions (SITL)
A Phase 3 study testing Retapamulin Ointment, 1% in people with Skin Infections, Bacterial, run by GlaxoSmithKline at 54 sites in 5 countries.
Trial 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. 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?
- Retapamulin Ointment, 1%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 508 participants
- Where
- 54 sitesin 5 countries
- Study dates
- May 2008to Oct 2009
- 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
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
54 sites in 5 countries.
54 sites in 5 countries
United States32 sites
GSK Investigational Site
Anaheim, California, 92804
GSK Investigational Site
Arlington Heights, Illinois, 60005
GSK Investigational Site
Bountiful, Utah, 84010
GSK Investigational Site
Brooklyn, New York, 11218
GSK Investigational Site
Brooklyn, New York, 11229
GSK Investigational Site
Butte, Montana, 59701
GSK Investigational Site
Cincinnati, Ohio, 45246
GSK Investigational Site
Colorado Springs, Colorado, 80904
GSK Investigational Site
Deerfield Beach, Florida, 33441
GSK Investigational Site
East Syracuse, New York, 13057
GSK Investigational Site
Fresno, California, 93710
GSK Investigational Site
Greenville, South Carolina, 29615
GSK Investigational Site
Hollywood, Florida, 33023
GSK Investigational Site
Houston, Texas, 77036
GSK Investigational Site
Irvine, California, 90620
GSK Investigational Site
Johnson City, New York, 13790
GSK Investigational Site
Kansas City, Kansas, 66160
GSK Investigational Site
Los Angeles, California, 90048
GSK Investigational Site
Miami, Florida, 33144
GSK Investigational Site
Miami, Florida, 33155
GSK Investigational Site
New Orleans, Louisiana, 70112
GSK Investigational Site
Norristown, Pennsylvania, 19401
GSK Investigational Site
Orlando, Florida, 32712
GSK Investigational Site
Panama City, Florida, 32401
GSK Investigational Site
Sacramento, California, 95825
GSK Investigational Site
Tampa, Florida, 33606
GSK Investigational Site
Teaneck, New Jersey, 07666
GSK Investigational Site
Tucson, Arizona, 85705
GSK Investigational Site
Uniontown, Pennsylvania, 15401
GSK Investigational Site
Vero Beach, Florida, 32960
GSK Investigational Site
Vienna, Virginia, 22180
GSK Investigational Site
West Palm Beach, Florida, 33401
South Africa10 sites
GSK Investigational Site
Belville, 7530
GSK Investigational Site
Benoni, 1501
GSK Investigational Site
Cape Town, 7572
GSK Investigational Site
Cape Town
GSK Investigational Site
Hatfield, 83
GSK Investigational Site
Lynnwood, 81
GSK Investigational Site
Midrand, 1
GSK Investigational Site
Newton, 6045
GSK Investigational Site
Welkom, 9460
GSK Investigational Site
Worcester, 6850
India5 sites
GSK Investigational Site
Bangalore, 560002
GSK Investigational Site
Lucknow, 226003
GSK Investigational Site
Pune
GSK Investigational Site
Vadodara, 390001
GSK Investigational Site
Wardha, 442102
Argentina4 sites
GSK Investigational Site
Buenos Aires, Buenos Aires, CP1431FWO
GSK Investigational Site
Buenos Aires, C1180AAX
GSK Investigational Site
Chivilocoy, Buenos Aires, 6620
GSK Investigational Site
Loma Hermosa, Buenos Aires, 1657
Brazil3 sites
GSK Investigational Site
Curitiba, Paraná, 80240-280
GSK Investigational Site
Curitiba/Paraná, Paraná, 80810-050
GSK Investigational Site
Passo Fundo, Rio Grande do Sul, 99010-080
About this study
Official title: A Randomized, Double-Blind, Multicenter, Placebo-controlled, Phase III Superiority Study to Assess the Safety and Efficacy of Topical Retapamulin Ointment, 1%, Versus Placebo Ointment Applied Twice Daily for 5 Days in the Treatment of Adult and Pediatric Subjects With SITL
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.
Read the detailed description
This is a prospective, multicenter, double-blind, placebo-controlled parallel group study in subjects aged 2 months and older with SITL, including secondarily-infected lacerations, sutured wounds or abrasions. A laceration or sutured wound cannot exceed 10 cm in length with surrounding erythema not extending more than 2 cm from the edge of the lesion. Abrasions cannot exceed 100 cm2 in total area, or up to a maximum of 2% total body surface area for subjects <18 years of age, with surrounding erythema not extending more than 2 cm from the edge of the abrasion.
There are four study visits occurring over a 12-14 day period. At the Baseline visit (Visit 1, Day 1), subjects will be randomized to receive retapamulin or placebo ointment in a 2:1 (retapamulin:placebo) ratio. The 2:1 randomization is included to minimize the number of subjects exposed to treatment with placebo. Both active treatment and placebo will be dosed topically twice daily (BID) for 5 days. All subjects will receive a telephone call from the investigator or appropriate designee appointed by the investigator on Day 2. The subject will be interviewed to determine if there is any evidence of worsening infection. Subjects who are thought to be worsening will be instructed to come in to the clinic for an assessment. Subjects will be monitored and clinically evaluated at the On-therapy (Days 3-4), End of Therapy (Days 7-9), and Follow-up (Days 12-14) visits.
Randomization will be center-based and performed using an appropriate Interactive Voice Response System (IVRS), an automated telephone system. The block size will remain confidential.
Subjects are considered to have completed the study if they meet all inclusion/exclusion criteria, are considered compliant with study medication, and attend all study visits as defined by the protocol.
- Conditions
- Skin Infections, Bacterial
- Being tested
- Retapamulin Ointment, 1%, Placebo ointment
- Keywords
- infection, retapamulin, secondarily-infected traumatic lesions, placebo
- Medical subject headings
- Cellulitis, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retapamulin Ointment, 1%Drug
Also called Retapamulin Ointment, 1%
Provided as approximately 10 grams of an off-white smooth ointment in collapsible aluminum tubes with reverse taper puncture tip caps.
Placebo ointmentDrug
Provided as approximately 10 grams of an off-white smooth ointment in collapsible aluminum tubes with reverse taper puncture tip caps.
| Study group | Role | What they receive |
|---|---|---|
| Retapamulin Ointment, 1% | Experimental | Not described Receives: Drug: Retapamulin Ointment, 1% |
| Placebo Ointment | Placebo comparator | Not described Receives: Drug: Placebo ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
"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.
Measured: Days 12-14
Number of Participants With Microbiological Success and Failure at Follow-up (7-9 Days Post Therapy)
The "by pathogen" microbiological outcome was determined by comparing the baseline culture results to those at follow-up. The "by subject" microbiological response was "Microbiological Success" if the microbiological outcomes for all baseline pathogens (bps) belong to "Eradication" (elimination of bps), "Presumed Eradication" (clinical outcome was success; no culture was obtained due to lack of culturable material), or "Colonization" (previously unidentified pathogen is identified at end of therapy in participant who is resolved/improved); otherwise, response was "Microbiological Failure".
Measured: Days 12-14
Number of Participants With the Indicated Clinical Outcome at End of Therapy (2-4 Days Post Therapy)
Clinical outcome is determined by the investigator based on signs and symptoms (S/S) at the end of therapy evaluation. The 4 clincal outcome categories are: clinical success, resolution of clinically meaningful S/S of infection recorded at baseline (BL), including a pus/exudates score of 0; clinical improvement, improvement of S/S of infection recorded at BL to such an extent that no further antimicrobial therapy is necessary; clinical failure, insufficient improvement of deterioration of S/S of infection recorded at BL such that additional antibiotic therapy is required; unable to determine.
Measured: Days 7-9
Number of Baseline Pathogens With the Indicated Microbiological Outcome at End of Therapy (2-4 Days Post Therapy)
The "by pathogen" microbiological outcome was determined by comparing the baseline culture results to those at follow-up. The results presented below pooled all baseline pathogens (bps). Eradication: elimination of bps. Presumed Eradication: clinical outcome was success; no culture was obtained due to lack of culturable material. Presumed Improvement: clinical outcome was improvement such that no culture was obtained due to lack of culturable material. Persistence: bps still present. Presumed persistence: clinical failure and no culture was obtained.
Measured: Days 7-9
Number of Participants With Therapeutic Success and Failure at Follow-up (7-9 Days Post Therapy)
"Therapeutic Success (Succ)" was referred to as both "Clinical Succ" and "Microbiological (Micro) Succ" at Follow-up. "Clinical Succ" was the "Resolution of baseline signs/symptoms of infection with a pus score of "0." A participant was "Micro Succ" if the micro outcome for all baseline pathogens (bps) belonged to "Eradication" (elimination of bps), "Presumed Eradication" (clinical outcome is success; no culturable material), or "Colonization" (new pathogen is identified at end of therapy in participants who are resolved/improved). All other combinations were deemed "Therapeutic Failures."
Measured: Follow-up (Days 12-14)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2008 (estimated)
- Study startMay 2008
- Primary completionOct 2009
- Study completionOct 2009
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.
- Other trials for Skin Infections, BacterialStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- 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
- 508 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00684177
- Sponsor's protocol ID
- TOC110977
- Status last verified
- Oct 2016
- First submitted
- 22 May 2008
- Last updated
- 23 Nov 2016
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Multicenter, Placebo-controlled, Phase III Superiority Study to Assess the Safety and Efficacy of Topical Retapamulin Ointment, 1%, Versus Placebo Ointment Applied Twice Daily for 5 Days in the Treatment of Adult and Pediatric Subjects With SITL
- ClinicalTrials.gov ID
- NCT00684177
- Acronym / sponsor ID
- TOC110977
- Conditions
- Skin Infections, Bacterial
- Keywords
- infection, retapamulin, secondarily-infected traumatic lesions, placebo
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 508 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 26 May 2008 (estimated)
- Results
- Posted 4 Aug 2010
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 Study TOC110977 is to demonstrate clinical superiority of Retapamulin ointment, 1%, over placebo in patients with secondarily-infected traumatic lesions, which includes secondarily-infected lacerations, abrasions and sutured wounds. Subjects 2 months of age and older will be treated with topical retapamulin or placebo ointment twice daily for 5 days. The primary endpoint of this study is the clinical response at follow-up (Day 12-14; 7-9 days after the end of therapy) in the intent-to-treat clinical population.
Detailed description
This is a prospective, multicenter, double-blind, placebo-controlled parallel group study in subjects aged 2 months and older with SITL, including secondarily-infected lacerations, sutured wounds or abrasions. A laceration or sutured wound cannot exceed 10 cm in length with surrounding erythema not extending more than 2 cm from the edge of the lesion. Abrasions cannot exceed 100 cm2 in total area, or up to a maximum of 2% total body surface area for subjects <18 years of age, with surrounding erythema not extending more than 2 cm from the edge of the abrasion.
There are four study visits occurring over a 12-14 day period. At the Baseline visit (Visit 1, Day 1), subjects will be randomized to receive retapamulin or placebo ointment in a 2:1 (retapamulin:placebo) ratio. The 2:1 randomization is included to minimize the number of subjects exposed to treatment with placebo. Both active treatment and placebo will be dosed topically twice daily (BID) for 5 days. All subjects will receive a telephone call from the investigator or appropriate designee appointed by the investigator on Day 2. The subject will be interviewed to determine if there is any evidence of worsening infection. Subjects who are thought to be worsening will be instructed to come in to the clinic for an assessment. Subjects will be monitored and clinically evaluated at the On-therapy (Days 3-4), End of Therapy (Days 7-9), and Follow-up (Days 12-14) visits.
Randomization will be center-based and performed using an appropriate Interactive Voice Response System (IVRS), an automated telephone system. The block size will remain confidential.
Subjects are considered to have completed the study if they meet all inclusion/exclusion criteria, are considered compliant with study medication, and attend all study visits as defined by the protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retapamulin Ointment, 1% | Experimental | Drug: Retapamulin Ointment, 1% |
| Placebo Ointment | Placebo comparator | Drug: Placebo ointment |
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)
- 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
Key exclusion criteria (13 listed)
- previous hypersensitivity to pleuromutilin
- secondarily-infected animal/human bite or puncture wound
- subject has an abscess
- chronic ulcerative lesion
- underlying skin disease
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 |
|---|---|---|
| Retapamulin Ointment, 1%Also: Retapamulin Ointment, 1%Provided as approximately 10 grams of an off-white smooth ointment in collapsible aluminum tubes with reverse taper puncture tip caps. | Drug | Retapamulin Ointment, 1% |
| Placebo ointmentProvided as approximately 10 grams of an off-white smooth ointment in collapsible aluminum tubes with reverse taper puncture tip caps. | Drug | Placebo Ointment |
Primary outcome
Number of Participants With Clinical Success and Failure at Follow-up (7-9 Days Post Therapy) for the Primary Efficacy Population
Time frame: Days 12-14
"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.
5 secondary outcomes
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
Time frame: Days 12-14
Number of Participants With Microbiological Success and Failure at Follow-up (7-9 Days Post Therapy)
Time frame: Days 12-14
Number of Participants With the Indicated Clinical Outcome at End of Therapy (2-4 Days Post Therapy)
Time frame: Days 7-9
Number of Baseline Pathogens With the Indicated Microbiological Outcome at End of Therapy (2-4 Days Post Therapy)
Time frame: Days 7-9
Number of Participants With Therapeutic Success and Failure at Follow-up (7-9 Days Post Therapy)
Time frame: Follow-up (Days 12-14)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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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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
54 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Retapamulin Ointment, 1% in people with Skin Infections, Bacterial, run by GlaxoSmithKline at 54 sites in 5 countries.
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 13 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 23 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in United States, South Africa, India, Argentina, Brazil. 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. Some participants in this study may receive a placebo. 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 4 Aug 2010). 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 With Clinical Success and Failure at Follow-up (7-9 Days Post Therapy) for the Primary Efficacy Population (time frame: Days 12-14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Nov 2016.