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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retapamulin Ointment, 1% | Experimental |
| |
| Placebo Ointment | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Retapamulin Ointment, 1% | Drug | Provided as approximately 10 grams of an off-white smooth ointment in collapsible aluminum tubes with reverse taper puncture tip caps. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Clinical Success and Failure at Follow-up (7-9 Days Post Therapy) for the Primary Efficacy Population | "Clinical Success" at follow-up was defined as "Resolution of clinically meaningful signs and symptoms of infection recorded at baseline including a pus/exudate Skin Infection Rating Scale (SIRS) score of "0". Clinical response at follow-up was classified as "Clinical Failure" for all other cases. The SIRS consists of seven items (pus/exudates, crusting, erythema/inflammation, tissue warmth, tissue edema, itching and pain). Each item has a score ranging from 0 to 6 (0=absent, 6=severe). The SIRS total score was calculated as the sum of the scores of all 7 SIRS items. | Days 12-14 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Tucson | Arizona | 85705 | United States | ||
| GSK Investigational Site |
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| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| TOC110977 | Annotated Case Report Form | View IPD |
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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A total of 508 participants were randomized. One participant did not receive treatment; thus, no data were collected for this participant. Only 507 participants were included in the analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | Retapamulin | Topical retapamulin ointment, 1% twice daily for 5 days |
| FG001 | Placebo | Matching placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo ointment | Drug | Provided as approximately 10 grams of an off-white smooth ointment in collapsible aluminum tubes with reverse taper puncture tip caps. |
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| 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". | 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. | 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. | 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." | Follow-up (Days 12-14) |
| Anaheim |
| California |
| 92804 |
| United States |
| GSK Investigational Site | Fresno | California | 93710 | United States |
| GSK Investigational Site | Irvine | California | 90620 | United States |
| GSK Investigational Site | Los Angeles | California | 90048 | United States |
| GSK Investigational Site | Sacramento | California | 95825 | United States |
| GSK Investigational Site | Colorado Springs | Colorado | 80904 | United States |
| GSK Investigational Site | Deerfield Beach | Florida | 33441 | United States |
| GSK Investigational Site | Hollywood | Florida | 33023 | United States |
| GSK Investigational Site | Miami | Florida | 33144 | United States |
| GSK Investigational Site | Miami | Florida | 33155 | United States |
| GSK Investigational Site | Orlando | Florida | 32712 | United States |
| GSK Investigational Site | Panama City | Florida | 32401 | United States |
| GSK Investigational Site | Tampa | Florida | 33606 | United States |
| GSK Investigational Site | Vero Beach | Florida | 32960 | United States |
| GSK Investigational Site | West Palm Beach | Florida | 33401 | United States |
| GSK Investigational Site | Arlington Heights | Illinois | 60005 | United States |
| GSK Investigational Site | Kansas City | Kansas | 66160 | United States |
| GSK Investigational Site | New Orleans | Louisiana | 70112 | United States |
| GSK Investigational Site | Butte | Montana | 59701 | United States |
| GSK Investigational Site | Teaneck | New Jersey | 07666 | United States |
| GSK Investigational Site | Brooklyn | New York | 11218 | United States |
| GSK Investigational Site | Brooklyn | New York | 11229 | United States |
| GSK Investigational Site | East Syracuse | New York | 13057 | United States |
| GSK Investigational Site | Johnson City | New York | 13790 | United States |
| GSK Investigational Site | Cincinnati | Ohio | 45246 | United States |
| GSK Investigational Site | Norristown | Pennsylvania | 19401 | United States |
| GSK Investigational Site | Uniontown | Pennsylvania | 15401 | United States |
| GSK Investigational Site | Greenville | South Carolina | 29615 | United States |
| GSK Investigational Site | Houston | Texas | 77036 | United States |
| GSK Investigational Site | Bountiful | Utah | 84010 | United States |
| GSK Investigational Site | Vienna | Virginia | 22180 | United States |
| GSK Investigational Site | Buenos Aires | Buenos Aires | CP1431FWO | Argentina |
| GSK Investigational Site | Chivilocoy | Buenos Aires | 6620 | Argentina |
| GSK Investigational Site | Loma Hermosa | Buenos Aires | 1657 | Argentina |
| GSK Investigational Site | Buenos Aires | C1180AAX | Argentina |
| GSK Investigational Site | Curitiba | Paraná | 80240-280 | Brazil |
| GSK Investigational Site | Curitiba/Paraná | Paraná | 80810-050 | Brazil |
| GSK Investigational Site | Passo Fundo | Rio Grande do Sul | 99010-080 | Brazil |
| GSK Investigational Site | Bangalore | 560002 | India |
| GSK Investigational Site | Lucknow | 226003 | India |
| GSK Investigational Site | Pune | India |
| GSK Investigational Site | Vadodara | 390001 | India |
| GSK Investigational Site | Wardha | 442102 | India |
| GSK Investigational Site | Belville | 7530 | South Africa |
| GSK Investigational Site | Benoni | 1501 | South Africa |
| GSK Investigational Site | Cape Town | 7572 | South Africa |
| GSK Investigational Site | Cape Town | South Africa |
| GSK Investigational Site | Hatfield | 83 | South Africa |
| GSK Investigational Site | Lynnwood | 81 | South Africa |
| GSK Investigational Site | Midrand | 1 | South Africa |
| GSK Investigational Site | Newton | 6045 | South Africa |
| GSK Investigational Site | Welkom | 9460 | South Africa |
| GSK Investigational Site | Worcester | 6850 | South Africa |
For additional information about this study please refer to the GSK Clinical Study Register |
| TOC110977 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| TOC110977 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| TOC110977 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| TOC110977 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| TOC110977 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| TOC110977 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Retapamulin | Topical retapamulin ointment, 1% twice daily for 5 days |
| BG001 | Placebo | Matching placebo |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | 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. | Primary Efficacy Population: ITTC participants (par.) with baseline pus/exudate >=3 who were enrolled under the original protocol with data captured under eCRF V1 and who were enrolled under protocol amendments with data captured under eCRF V2; ITTC (Intent-to-treat Clinical): all randomized par. who received at least one dose of study medication. | Posted | Number | participants | Days 12-14 |
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| Secondary | 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. | ITTB subset of Primary Efficacy Population: participants in the Primary Efficacy Population (see analysis population description in the Primary Outcome section) who had at least one pathogen isolated at the baseline visit. | Posted | Number | participants | Days 12-14 |
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| Secondary | 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". | ITTB subset of Primary Efficacy Population | Posted | Number | participants | Days 12-14 |
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| Secondary | 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. | Primary Efficacy Population | Posted | Number | participants | Days 7-9 |
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| Secondary | 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. | ITTB subset of Primary Efficacy Population | Posted | Number | baseline pathogens | Days 7-9 |
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| Secondary | 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." | ITTB subset of Primary Efficacy Population | Posted | Number | participants | Follow-up (Days 12-14) |
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Adverse events (AEs) were recorded from the first dose of study medication until study completion. Serious AEs (SAEs) were collected from the time of consent and continued until study completion (including the Follow-up Period).
AEs were collected for all randomized participants (par.) who received at least one dose of study medications (i.e., ITTC Population). Safety data were analyzed based on the actual treatment received. One par. who was randomized to retapamulin treatment but actually received placebo was included in the placebo arm for the safety analyses.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Retapamulin | Topical retapamulin ointment, 1% twice daily for 5 days | 1 | 342 | 8 | 342 | ||
| EG001 | Placebo | Matching placebo | 1 | 165 | 4 | 165 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
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| Pneumococcal pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site pain | General disorders | MedDRA | Systematic Assessment |
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| Condition aggravated | General disorders | MedDRA | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA | Systematic Assessment |
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GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D002481 | Cellulitis |
| D007239 | Infections |
| ID | Term |
|---|---|
| D012874 | Skin Diseases, Infectious |
| D013492 | Suppuration |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Male |
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| American Indian or Alaskan Native |
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| Asian - Central / South Asian Heritage |
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| Asian - East Asian Heritage |
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| Asian - South East Asian Heritage |
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| Native Hawaiian or Other Pacific Islander |
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| White - Arabic/North African Heritage |
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| White - White/Caucasian/European Heritage |
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| Mixed Race |
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