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EU PV for Retapamulin-Prescribing

NCT01153828 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1

Last updated 2013-06-10

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2012-08-31
Completion
2012-08-31

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01153828 on ClinicalTrials.gov