EU PV for Retapamulin-Prescribing

Completed

• Conditions: Impetigo
• Interventions: Drug: Retapamulin; Drug: Co-prescription of retapamulin and topical mupirocin; Drug: Co-prescription of retapamulin and topical fusidic acid

• Registration Number: NCT01153828
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2010-05-13
• Study First Submitted QC: 2010-06-29
• Study First Posted: 2010-06-30
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2013-05
• Last Update Submitted: 2013-06-06
• Last Update Posted: 2013-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
(3) 7 years to 18 years	Retapamulin	Age at time of prescription was 7 years to 18 years
(1) Age <9 months	Co-prescription of retapamulin and topical mupirocin	Age at time of prescription was \<9 months
(1) Age <9 months	Co-prescription of retapamulin and topical fusidic acid	Age at time of prescription was \<9 months
(2) 9 months to 6 years	Retapamulin	Age at time of prescription was 9 months to 6 years
(2) 9 months to 6 years	Co-prescription of retapamulin and topical mupirocin	Age at time of prescription was 9 months to 6 years
(2) 9 months to 6 years	Co-prescription of retapamulin and topical fusidic acid	Age at time of prescription was 9 months to 6 years
(3) 7 years to 18 years	Co-prescription of retapamulin and topical mupirocin	Age at time of prescription was 7 years to 18 years
(3) 7 years to 18 years	Co-prescription of retapamulin and topical fusidic acid	Age at time of prescription was 7 years to 18 years
(4) 19 to 65 years	Co-prescription of retapamulin and topical fusidic acid	Age at time of prescription was 19 to 65 years
(5) 66 years and older	Retapamulin	Age at time of prescription was 66 years and older
(5) 66 years and older	Co-prescription of retapamulin and topical mupirocin	Age at time of prescription was 66 years and older
(5) 66 years and older	Co-prescription of retapamulin and topical fusidic acid	Age at time of prescription was 66 years and older
(4) 19 to 65 years	Co-prescription of retapamulin and topical mupirocin	Age at time of prescription was 19 to 65 years
(1) Age <9 months	Retapamulin	Age at time of prescription was \<9 months
(4) 19 to 65 years	Retapamulin	Age at time of prescription was 19 to 65 years

Primary Outcome Measures

Name	Time	Method
Prescription for retapamulin	First prescription in database for each calendar year between January 2007 and December 2011

Secondary Outcome Measures

Name	Time	Method
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