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The purpose of the study is to show non inferiority in terms of safety and efficacy of topical administration BID (Twice daily) of Mupirocin Gel 20 mg/g compared to topical administration of Mupirocin Ointment 20 mg/g TID (three times daily) (Bactroban) in the treatment of impetigo in paediatric population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mupirocin gel | Experimental | Topical administration of Mupirocin gel 20 mg/g BID for 7 days |
|
| Mupirocin ointment | Active Comparator | Topical administration of Mupirocin ointment 20mg/g TID for 7 days. |
|
| Placebo | Placebo Comparator | Topical administration of Placebo (ointment) TID for 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mupirocin gel | Drug | Topical administration of Mupirocin gel 20 mg/g BID for 7 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical cure at the end of treatment by SIRS assessed by blind observer | Proportion of subjects with clinical cure at the Day 8 visit, assessed by blind observer, according to criteria described in the Protocol (SIRS < or = 2). | Day 8 |
| Clinical cure as assessed by the proportion of subjects with no additional antibiotic therapy required to treat impetigo at day 8 | proportion of subjects with no additional antibiotic therapy required to treat impetigo | Day 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical cure at the end of follow up by SIRS assessed by blind observer | Proportion of subjects with clinical cure at the Day 14 visit, assessed by blind observer, according to criteria described in the protocol (SIRS < or = 2). | Day14 |
| Clinical cure as assessed by the proportion of subjects with no additional antibiotic therapy required to treat impetigo at day 14 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raúl De Lucas, Dr. | Hospital La Paz | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CAP Torreblanca | Seville | Andalusia | 41016 | Spain | ||
| CAP La Algaba |
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| ID | Term |
|---|---|
| D007169 | Impetigo |
| ID | Term |
|---|---|
| D013207 | Staphylococcal Skin Infections |
| D013203 | Staphylococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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| ID | Term |
|---|---|
| D016712 | Mupirocin |
| ID | Term |
|---|---|
| D004852 | Epoxy Compounds |
| D004988 | Ethers, Cyclic |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
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| Mupirocin ointment |
| Drug |
Topical treatment of Mupirocin ointment 20 mg/g TID for 7 days |
|
|
| Placebo | Drug | Topical administration of Placebo (ointment) TID during 7 days |
|
proportion of subjects with no additional antibiotic therapy required to treat impetigo |
| Day14 |
| Total SIRS score at the end of treatment and follow-up by blind observer | Day 8 and 14 |
| Bacteriology cure at follow-up | Bacteriology eradication at the end of follow-up period according to culture at screening and follow up visits | Day 14 |
| Clinical cure at the end of treatment and follow-up by investigator | Proportion of subjects with clinical cure at the Day 8 and Day 14 visits, assessed by investigator, according to protocol criteria. | Day 8 and 14 |
| SIRS total score at the end of treatment and follow-up by investigator | SIRS total Score at Day 8 and Day 14 visits, assessed by the investigator | Day 8 and 14 |
| Seville |
| Andalusia |
| 41980 |
| Spain |
| CAP Vallcarca-St. Gervasi | Barcelona | Catalonia | 08023 | Spain |
| CAP Corbera de Llobregat | Corbera de Llobregat | Catalonia | 08757 | Spain |
| CAP Amadeu Torner | L'Hospitalet de Llobregat | Catalonia | 08902 | Spain |
| CAP Mossèn Cinto Verdager | L'Hospitalet de Llobregat | Catalonia | 08902 | Spain |
| CAP Florida Nord | L'Hospitalet de Llobregat | Catalonia | 08905 | Spain |
| CAP Rambla Ferran | Lleida | Catalonia | 25007 | Spain |
| CAP Maria Bernades | Viladecans | Catalonia | 08840 | Spain |
| H.U. Sureste | Arganda | Madrid | 28500 | Spain |
| H.U. Fuenlabrada | Fuenlabrada | Madrid | 21942 | Spain |
| CAP Castilla la Nueva | Fuenlabrada | Madrid | 28945 | Spain |
| CAP Pinto | Pinto | Madrid | 28320 | Spain |
| CAP Pozuelo de Alarcón | Pozuelo de Alarcón | Madrid | 28224 | Spain |
| H.U. Infanta Sofía | San Sebastián de los Reyes | Madrid | 28702 | Spain |
| CAP Cea Bermúdez | Madrid | 28003 | Spain |
| Hospital Gregorio MArañón | Madrid | 28007 | Spain |
| CAP Campo de la Paloma | Madrid | 28018 | Spain |
| CAP Aravaca | Madrid | 28023 | Spain |
| CAP La Calesas | Madrid | 28026 | Spain |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D013290 | Streptococcal Infections |
| D017192 | Skin Diseases, Bacterial |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D011714 |
| Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005227 | Fatty Acids |
| D008055 | Lipids |