EU PV for Retapamulin-Prescribing

NCT ID: NCT01153828

Last Updated: 2013-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-11-30

Study Completion Date

2012-08-31

Brief Summary

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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

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Conditions

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Impetigo

Study Design

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Study Time Perspective

RETROSPECTIVE

Study Groups

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(1) Age <9 months

Age at time of prescription was \<9 months

Retapamulin

Intervention Type DRUG

Prescription for retapamulin

Co-prescription of retapamulin and topical mupirocin

Intervention Type DRUG

Same day prescriptions for retapamulin and topical mupirocin

Co-prescription of retapamulin and topical fusidic acid

Intervention Type DRUG

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

Retapamulin

Intervention Type DRUG

Prescription for retapamulin

Co-prescription of retapamulin and topical mupirocin

Intervention Type DRUG

Same day prescriptions for retapamulin and topical mupirocin

Co-prescription of retapamulin and topical fusidic acid

Intervention Type DRUG

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

Retapamulin

Intervention Type DRUG

Prescription for retapamulin

Co-prescription of retapamulin and topical mupirocin

Intervention Type DRUG

Same day prescriptions for retapamulin and topical mupirocin

Co-prescription of retapamulin and topical fusidic acid

Intervention Type DRUG

Same day prescription for retapamulin and fusidic acid.

(4) 19 to 65 years

Age at time of prescription was 19 to 65 years

Retapamulin

Intervention Type DRUG

Prescription for retapamulin

Co-prescription of retapamulin and topical mupirocin

Intervention Type DRUG

Same day prescriptions for retapamulin and topical mupirocin

Co-prescription of retapamulin and topical fusidic acid

Intervention Type DRUG

Same day prescription for retapamulin and fusidic acid.

(5) 66 years and older

Age at time of prescription was 66 years and older

Retapamulin

Intervention Type DRUG

Prescription for retapamulin

Co-prescription of retapamulin and topical mupirocin

Intervention Type DRUG

Same day prescriptions for retapamulin and topical mupirocin

Co-prescription of retapamulin and topical fusidic acid

Intervention Type DRUG

Same day prescription for retapamulin and fusidic acid.

Interventions

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Retapamulin

Prescription for retapamulin

Intervention Type DRUG

Co-prescription of retapamulin and topical mupirocin

Same day prescriptions for retapamulin and topical mupirocin

Intervention Type DRUG

Co-prescription of retapamulin and topical fusidic acid

Same day prescription for retapamulin and fusidic acid.

Intervention Type DRUG

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Other Identifiers

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113149

Identifier Type: -

Identifier Source: org_study_id

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