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The goal of this study is to determine if topical SB-275833 ointment, 1% is as safe and effective as topical sodium fusidate ointment, 2% for the treatment of impetigo in adults and children as young as 9 months of age.
A Randomised, Observer-blind, Multicentre, Non-inferiority, Comparative, Phase III Study of the Safety and Efficacy of Topical 1% SB-275833 Ointment, Applied Twice Daily for 5 Days, versus Topical 2% Sodium Fusidate Ointment Applied Three Times Daily for 7 Days in the Treatment of Adult and Paediatric Subjects with Impetigo.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SB-275833 ointment, 1% | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical response assessed at end of therapy visit. Clinical success defined by the need for no additional antibiotic treatment. | 7 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical response assessed at follow up visit. Microbiologic response at end of therapy and follow up visits. Impetigo lesion area measured at end of therapy and follow up visits. | 7 Days |
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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 | Winnipeg | Manitoba | R3A 1M3 | Canada | ||
| 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 |
|---|---|---|---|
| TOC100224 | 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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| Winnipeg |
| Manitoba |
| R3C 0N2 |
| Canada |
| GSK Investigational Site | St. John's | Newfoundland and Labrador | A1E 2C2 | Canada |
| GSK Investigational Site | Brampton | Ontario | L6T 3J1 | Canada |
| GSK Investigational Site | Greater Sudbury | Ontario | P3E 6B4 | Canada |
| GSK Investigational Site | Kitchener | Ontario | N2C 2N9 | Canada |
| GSK Investigational Site | Toronto | Ontario | M9W 4L6 | Canada |
| GSK Investigational Site | San José | Costa Rica |
| GSK Investigational Site | Anzin | 59410 | France |
| GSK Investigational Site | Bersée | 59235 | France |
| GSK Investigational Site | Labarth-Sur-Leze | 31860 | France |
| GSK Investigational Site | Martigues | 13500 | France |
| GSK Investigational Site | Paris | 75020 | France |
| GSK Investigational Site | Seraincourt | 95450 | France |
| GSK Investigational Site | Vieux-Condé | 59690 | France |
| GSK Investigational Site | Augsburg | Bavaria | 86179 | Germany |
| GSK Investigational Site | Gilching | Bavaria | 82205 | Germany |
| GSK Investigational Site | Munich | Bavaria | 80801 | Germany |
| GSK Investigational Site | Munich | Bavaria | 81241 | Germany |
| GSK Investigational Site | Mahlow | Brandenburg | 15831 | Germany |
| GSK Investigational Site | Duelmen | Lower Saxony | 48249 | Germany |
| GSK Investigational Site | Bad Honnef | North Rhine-Westphalia | 53604 | Germany |
| GSK Investigational Site | Bonn | North Rhine-Westphalia | 53177 | Germany |
| GSK Investigational Site | Cologne | North Rhine-Westphalia | 50674 | Germany |
| GSK Investigational Site | Düsseldorf | North Rhine-Westphalia | 40472 | Germany |
| GSK Investigational Site | Gelsenkirchen | North Rhine-Westphalia | 45879 | Germany |
| GSK Investigational Site | Kleve-Materborn | North Rhine-Westphalia | 47533 | Germany |
| GSK Investigational Site | Krefeld | North Rhine-Westphalia | 47798 | Germany |
| GSK Investigational Site | Mülheim | North Rhine-Westphalia | 45468 | Germany |
| GSK Investigational Site | Olpe | North Rhine-Westphalia | 57462 | Germany |
| GSK Investigational Site | Unna | North Rhine-Westphalia | 59423 | Germany |
| GSK Investigational Site | Wuppertal | North Rhine-Westphalia | 42103 | Germany |
| GSK Investigational Site | Worms | Rhineland-Palatinate | 67547 | Germany |
| GSK Investigational Site | Döbeln | Saxony | 04720 | Germany |
| GSK Investigational Site | Dresden | Saxony | 01097 | Germany |
| GSK Investigational Site | Reichenbach | Saxony | 08468 | Germany |
| GSK Investigational Site | Schmiedeberg | Saxony | 01762 | Germany |
| GSK Investigational Site | Kiel | Schleswig-Holstein | 24103 | Germany |
| GSK Investigational Site | Kiel | Schleswig-Holstein | 24148 | Germany |
| GSK Investigational Site | Preetz | Schleswig-Holstein | 24211 | Germany |
| GSK Investigational Site | Rendsburg | Schleswig-Holstein | 24768 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 10435 | Germany |
| GSK Investigational Site | Bangalore | 560002 | India |
| GSK Investigational Site | Bangalore | 560034 | India |
| GSK Investigational Site | Mumbai | 400 008 | India |
| GSK Investigational Site | Zapopan, Jalisco | Jalisco | 45190 | Mexico |
| GSK Investigational Site | Mexico City | 06780 | Mexico |
| GSK Investigational Site | Ermelo | 3851 EX | Netherlands |
| GSK Investigational Site | Huizen | 1271 BB | Netherlands |
| GSK Investigational Site | Losser | 7581 BV | Netherlands |
| GSK Investigational Site | Musselkanaal | 9581 AJ | Netherlands |
| GSK Investigational Site | Oude Pekela | 9665 AR | Netherlands |
| GSK Investigational Site | Sittard | 6131 BK | Netherlands |
| GSK Investigational Site | Soerendonk | 6027 RN | Netherlands |
| GSK Investigational Site | Zieuwent | 7136 KH | Netherlands |
| GSK Investigational Site | Zwijndrecht | 3331 LZ | Netherlands |
| GSK Investigational Site | Breña | Lima 5 | Peru |
| GSK Investigational Site | Grudziądz | 86-300 | Poland |
| GSK Investigational Site | Katowice | 40-027 | Poland |
| GSK Investigational Site | Poznan | 60-355 | Poland |
| GSK Investigational Site | Wroclaw | 50-368 | Poland |
| GSK Investigational Site | Zabrze | 41-800 | Poland |
| GSK Investigational Site | Cape Town | 7460 | South Africa |
| GSK Investigational Site | Cape Town | 7925 | South Africa |
| GSK Investigational Site | Daveyton | 1520 | South Africa |
| GSK Investigational Site | Eloffsdal, Pretoria | 0084 | South Africa |
| GSK Investigational Site | Newtown | 2113 | South Africa |
| GSK Investigational Site | Pretoia | 0084 | South Africa |
| GSK Investigational Site | Pretoria | 0001 | South Africa |
For additional information about this study please refer to the GSK Clinical Study Register |
| TOC100224 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| TOC100224 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| TOC100224 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| TOC100224 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| TOC100224 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| TOC100224 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ID | Term |
|---|---|
| D002481 | Cellulitis |
| D007169 | Impetigo |
| ID | Term |
|---|---|
| D012874 | Skin Diseases, Infectious |
| D007239 | Infections |
| D013492 | Suppuration |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013207 | Staphylococcal Skin Infections |
| D013203 | Staphylococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D013290 | Streptococcal Infections |
| D017192 | Skin Diseases, Bacterial |
| D012871 | Skin Diseases |
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