United States Pharmacovigilence Retapamulin-Prescribing

NCT01153880 | Completed

• 1 other identifier: 113158
• Study Type: observational
• Target: 1
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Skin Infections, Bacterial

Keywords

Altabax; United States; topical; Mupirocin; Retapamulin; Bactroban

Outcome Measures

Primary Outcomes (1)

• Prescription of retapamulin

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

Secondary Outcomes (1)

• Prescription for retapamulin and topical mupirocin

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

Study Arms (6)

Age <9 months definitive

Age at time of prescription was \<9 months

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

Age <9 months uncertain

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

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

9 months to 6 years

Age at time of prescription was 9 months to 6 years

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

7 to 18 years

Age at time of prescription was 7 to 18 years

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

19 to 65 years

Age at time of prescription was 19 to 65 years

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

66 years and older

Age at time of prescription was 66 years and older

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

Interventions

Retapamulin DRUG

Prescription sales claim of retapamulin

19 to 65 years; 66 years and older; 7 to 18 years; 9 months to 6 years; Age <9 months definitive; Age <9 months uncertain

Co-prescription of retapamulin and topical mupirocin DRUG

Same day prescription sales claims for retapamulin and topical mupirocin

19 to 65 years; 66 years and older; 7 to 18 years; 9 months to 6 years; Age <9 months definitive; Age <9 months uncertain

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Members with enrollment and phamacy benefits eligibility in the Integrated Health Care Information Services (IHCIS) National Managed Care Benchmarked Database will be assessed annually for prescription sales claims for five years post-launch of retapamulin. The IHCIS is a US national managed care database which is Health Insurance Portability and Accountability Act (HIPAA) compliant and features encrypted member and provider identifiers.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Cellulitis

Interventions

retapamulin; Mupirocin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epoxy Compounds; Ethers, Cyclic; Ethers; Organic Chemicals; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fatty Acids; Lipids

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2010
• First Posted: June 30, 2010
• Study Start: December 1, 2008
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: June 10, 2013

Record last verified: 2013-05