NCT01153828

EU PV for Retapamulin-Prescribing

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Impetigo

Interventions

Type	Name	Description
DRUG	Retapamulin	Prescription for retapamulin
DRUG	Co-prescription of retapamulin and topical mupirocin	Same day prescriptions for retapamulin and topical mupirocin
DRUG	Co-prescription of retapamulin and topical fusidic acid	Same day prescription for retapamulin and fusidic acid.

Timeline

• Start date: 2008-11-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2010-06-30
• Last updated: 2013-06-10