EU PV for Retapamulin-Prescribing

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Impetigo

Treatments: Drug: Co-prescription of retapamulin and topical mupirocin; Drug: Co-prescription of retapamulin and topical fusidic acid; Drug: Retapamulin

Study type: Observational

Funder types: Industry

Identifiers

NCT01153828

113149

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

1 participants in 5 patient groups

(1) Age <9 months

Description:

Age at time of prescription was \<9 months

Treatment:

Drug: Co-prescription of retapamulin and topical fusidic acid

Drug: Co-prescription of retapamulin and topical mupirocin

Drug: Retapamulin

(2) 9 months to 6 years

Description:

Age at time of prescription was 9 months to 6 years

Treatment:

Drug: Co-prescription of retapamulin and topical fusidic acid

Drug: Co-prescription of retapamulin and topical mupirocin

Drug: Retapamulin

(3) 7 years to 18 years

Description:

Age at time of prescription was 7 years to 18 years

Treatment:

Drug: Co-prescription of retapamulin and topical fusidic acid

Drug: Co-prescription of retapamulin and topical mupirocin

Drug: Retapamulin

(4) 19 to 65 years

Description:

Age at time of prescription was 19 to 65 years

Treatment:

Drug: Co-prescription of retapamulin and topical fusidic acid

Drug: Co-prescription of retapamulin and topical mupirocin

Drug: Retapamulin

(5) 66 years and older

Description:

Age at time of prescription was 66 years and older

Treatment:

Drug: Co-prescription of retapamulin and topical fusidic acid

Drug: Co-prescription of retapamulin and topical mupirocin

Drug: Retapamulin