EU PV for Retapamulin-Prescribing

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

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.

Study Overview

• Status: Completed
• Conditions: Impetigo
• Intervention / Treatment: Drug: Retapamulin; Drug: Co-prescription of retapamulin and topical mupirocin; Drug: Co-prescription of retapamulin and topical fusidic acid

• Study Type: Observational
• Enrollment (Actual): 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The GPRD contains detailed information for a sample of patients from representative general practices throughout the United Kingdom. Patient data included in the GPRD were drawn from the computer systems used by general practitioners to maintain the clinical records within their practices and contain all records deemed relevant to patient care. Prescriptions of Altabax, Altargo, Mupirocin and Fucidin will be captured.

Description

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 Plan

How is the study designed?

Design Details

• Time Perspectives: Retrospective

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
(1) Age <9 months; Age at time of prescription was <9 months	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.
(2) 9 months to 6 years; Age at time of prescription was 9 months to 6 years	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.
(3) 7 years to 18 years; Age at time of prescription was 7 years to 18 years	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.
(4) 19 to 65 years; Age at time of prescription was 19 to 65 years	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.
(5) 66 years and older; Age at time of prescription was 66 years and older	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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: May 13, 2010
• First Submitted That Met QC Criteria: June 29, 2010
• First Posted (Estimate): June 30, 2010

Study Record Updates

• Last Update Posted (Estimate): June 10, 2013
• Last Update Submitted That Met QC Criteria: June 6, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: topical; United Kingdom; Altargo; Bactroban; Fucidin; Fusidic acid; Mupirocin; Retapamulin
• Additional Relevant MeSH Terms: Skin Diseases; Infections; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Skin Diseases, Infectious; Staphylococcal Infections; Skin Diseases, Bacterial; Staphylococcal Skin Infections; Impetigo; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Mupirocin; Fusidic Acid; Retapamulin
• Other Study ID Numbers: 113149