EU PV for Retapamulin-Prescribing

Study Overview
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Brief Summary
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Retapamulin, a topical pleuromutilin antibiotic, is the first in a new class of topical antibiotics approved for human use. In the European Union (EU), retapamulin is approved for the treatment of impetigo and secondarily-infected traumatic lesions in persons nine or more months of age. This study is designed to examine retapamulin use in the pediatric population less than nine months of age. We will conduct a five-year assessment of prescriptions for retapamulin using the General Practice Research Database. For each year of reporting, the observed frequencies of prescriptions of retapamulin, with or without same-day co-prescriptions of topical mupirocin or fusidic acid, will be identified. The five-year reporting period will include five years of distinct, non-overlapping, non-cumulative prescription use of first exposure to retapamulin, with or without same-day co-prescription of topical mupirocin or fusidic acid.

Official Title
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Pharmacovigilence for Retapamulin: Age-stratified Monitoring of Prescribed Use in the European Union

Conditions
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Impetigo

Intervention / Treatment
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* Drug: Retapamulin
* Drug: Co-prescription of retapamulin and topical mupirocin
* Drug: Co-prescription of retapamulin and topical fusidic acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The study population will consist of all registered research standard patients on GPRD, as evaluated annually for five years. For each year of observation, the denominator of persons will be patients registered for at least one month during the prior calendar year. Hence, the five-year reporting period for distinct, non-overlapping, non-cumulative prescription use and will categorize persons by date of birth (mm/dd/year). Exclusion Criteria: Enrollment in GPRD of less than one month duration.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| (1) Age <9 months<br>Age at time of prescription was <9 months | Drug: Retapamulin<br>* Prescription for retapamulin<br>Drug: Co-prescription of retapamulin and topical mupirocin<br>* Same day prescriptions for retapamulin and topical mupirocin<br>Drug: Co-prescription of retapamulin and topical fusidic acid<br>* Same day prescription for retapamulin and fusidic acid.<br>|
| (2) 9 months to 6 years<br>Age at time of prescription was 9 months to 6 years | Drug: Retapamulin<br>* Prescription for retapamulin<br>Drug: Co-prescription of retapamulin and topical mupirocin<br>* Same day prescriptions for retapamulin and topical mupirocin<br>Drug: Co-prescription of retapamulin and topical fusidic acid<br>* Same day prescription for retapamulin and fusidic acid.<br>|
| (3) 7 years to 18 years<br>Age at time of prescription was 7 years to 18 years | Drug: Retapamulin<br>* Prescription for retapamulin<br>Drug: Co-prescription of retapamulin and topical mupirocin<br>* Same day prescriptions for retapamulin and topical mupirocin<br>Drug: Co-prescription of retapamulin and topical fusidic acid<br>* Same day prescription for retapamulin and fusidic acid.<br>|
| (4) 19 to 65 years<br>Age at time of prescription was 19 to 65 years | Drug: Retapamulin<br>* Prescription for retapamulin<br>Drug: Co-prescription of retapamulin and topical mupirocin<br>* Same day prescriptions for retapamulin and topical mupirocin<br>Drug: Co-prescription of retapamulin and topical fusidic acid<br>* Same day prescription for retapamulin and fusidic acid.<br>|
| (5) 66 years and older<br>Age at time of prescription was 66 years and older | Drug: Retapamulin<br>* Prescription for retapamulin<br>Drug: Co-prescription of retapamulin and topical mupirocin<br>* Same day prescriptions for retapamulin and topical mupirocin<br>Drug: Co-prescription of retapamulin and topical fusidic acid<br>* Same day prescription for retapamulin and fusidic acid.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prescription for retapamulin |  | First prescription in database for each calendar year between January 2007 and December 2011 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Co-prescription of retapamulin and topical mupirocin |  | First same-day prescriptions for both medicines in database for each calendar year between January 2007 and December 2011 | 
| Co-prescription of retapamulin and topical fusidic acid |  | First same-day prescriptons for both medicines in database for each calendar year between January 2007 and December 2011 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Altargo, Bactroban, Fucidin, Fusidic acid, Mupirocin, topical, Retapamulin, United Kingdom