Skip to content

EU PV for Retapamulin-Prescribing

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01153828
Enrollment
1
Registered
2010-06-30
Start date
2008-11-30
Completion date
2012-08-31
Last updated
2013-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Impetigo

Keywords

Altargo, Bactroban, Fucidin, Fusidic acid, Mupirocin, topical, Retapamulin, United Kingdom

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.

Interventions

Prescription for retapamulin

Same day prescriptions for retapamulin and topical mupirocin

DRUGCo-prescription of retapamulin and topical fusidic acid

Same day prescription for retapamulin and fusidic acid.

Sponsors

GlaxoSmithKline
Lead SponsorINDUSTRY

Study design

Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Prescription for retapamulinFirst prescription in database for each calendar year between January 2007 and December 2011

Secondary

MeasureTime frame
Co-prescription of retapamulin and topical mupirocinFirst 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 acidFirst same-day prescriptons for both medicines in database for each calendar year between January 2007 and December 2011

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026