United States Pharmacovigilence Retapamulin-Prescribing

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Skin Infections, Bacterial

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

Study type: Observational

Funder types: Industry

Identifiers

NCT01153880

113158

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 United States (US), retapamulin is approved for the treatment of impetigo in persons nine or more months of age and was launched on 12 April 2007. This five-year study is designed to examine use of retapamulin in the pediatric population less than nine months of age. We will conduct an annual assessment of prescription sales claims for retapamulin using the Integrated Health Care Information Services (IHCIS) National Managed Care Benchmarked Database. For each year of reporting, the observed frequencies of the exposure, with or without same-day, co-prescribed sales claim of mupirocin, will be identified. The study objectives are to determine the frequency of retapamulin sales in a representative US population stratified by the designated age group and to determine the frequency of same-day sale of the topical agent, mupirocin.

Full description

The IHCIS is Health Insurance Portability and Accountability Act (HIPAA) compliant with encrypted member and provider identifiers; date of birth is restricted to year of birth. Based on year of birth and the prescription sales claim date, age at the time of the prescription(s) will be categorized as less than 9 months (definitive) and less than 9 months (uncertain).

Enrollment: 1 patient

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• The study population will consist of all 'eligible members' in the IHCIS database with a valid gender and age record who have at least 1 month enrolment and eligibility of pharmacy benefits.

Exclusion criteria

• Membership in IHCIS without a valid gender or age record, enrolment less than 1 month, or ineligibility for pharmacy benefits will be excluded.

Trial design

1 participants in 6 patient groups

Age <9 months definitive

Description:

Age at time of prescription was \<9 months

Treatment:

Drug: Co-prescription of retapamulin and topical mupirocin

Drug: Retapamulin

Age <9 months uncertain

Description:

Age at time of prescription was uncertain for \<9 months

Treatment:

Drug: Co-prescription of retapamulin and topical mupirocin

Drug: Retapamulin

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 mupirocin

Drug: Retapamulin

7 to 18 years

Description:

Age at time of prescription was 7 to 18 years

Treatment:

Drug: Co-prescription of retapamulin and topical mupirocin

Drug: Retapamulin

19 to 65 years

Description:

Age at time of prescription was 19 to 65 years

Treatment:

Drug: Co-prescription of retapamulin and topical mupirocin

Drug: Retapamulin

66 years and older

Description:

Age at time of prescription was 66 years and older

Treatment:

Drug: Co-prescription of retapamulin and topical mupirocin

Drug: Retapamulin