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Completed

NCT Number: NCT01153880

United States Pharmacovigilence Retapamulin-Prescribing

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.

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Key information

Conditions

Skin Infections, Bacterial Cellulitis Connective Tissue Diseases Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases, Infectious Skin and Connective Tissue Diseases Suppuration

Sex eligibility

All sexes

Study type

Observational

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Retapamulin

Drug

Prescription sales claim of retapamulin

Co-prescription of retapamulin and topical mupirocin

Drug

Same day prescription sales claims for retapamulin and topical mupirocin

Primary outcomes

  1. Prescription of retapamulin

    Time frame: First prescription in database for each calendar year between January 2007 and December 2011

Secondary outcomes

  1. Prescription for retapamulin and topical mupirocin

    Time frame: First same-day prescriptions for both medicines in database for each calendar year between Janaury 2007 and December 2011

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Pharmacovigilence for Retapamulin: Age-stratified Monitoring of Prescribed Use in the United States

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Jun 30, 2010
Registry last updated
Jun 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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