EU PV for Retapamulin-Prescribing

NCT01153828 | Completed

• 1 other identifier: 113149
• 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 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.

Conditions

Impetigo

Keywords

Altargo; Bactroban; Fucidin; Fusidic acid; Mupirocin; topical; Retapamulin; United Kingdom

Outcome Measures

Primary Outcomes (1)

• Prescription for retapamulin

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

Secondary Outcomes (2)

• Co-prescription of retapamulin and topical mupirocin

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

• Co-prescription of retapamulin and topical fusidic acid

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

Study Arms (5)

(1) Age <9 months

Age at time of prescription was \<9 months

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

(2) 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; Drug: Co-prescription of retapamulin and topical fusidic acid

(3) 7 years to 18 years

Age at time of prescription was 7 years to 18 years

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

(4) 19 to 65 years

Age at time of prescription was 19 to 65 years

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

(5) 66 years and older

Age at time of prescription was 66 years and older

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

Interventions

Retapamulin DRUG

Prescription for retapamulin

(1) Age <9 months; (2) 9 months to 6 years; (3) 7 years to 18 years; (4) 19 to 65 years; (5) 66 years and older

Co-prescription of retapamulin and topical mupirocin DRUG

Same day prescriptions for retapamulin and topical mupirocin

(1) Age <9 months; (2) 9 months to 6 years; (3) 7 years to 18 years; (4) 19 to 65 years; (5) 66 years and older

Co-prescription of retapamulin and topical fusidic acid DRUG

Same day prescription for retapamulin and fusidic acid.

(1) Age <9 months; (2) 9 months to 6 years; (3) 7 years to 18 years; (4) 19 to 65 years; (5) 66 years and older

Eligibility Criteria

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

Study Population

The GPRD contains detailed information for a sample of patients from representative general practices throughout the United Kingdom. Patient data included in the GPRD were drawn from the computer systems used by general practitioners to maintain the clinical records within their practices and contain all records deemed relevant to patient care. Prescriptions of Altabax, Altargo, Mupirocin and Fucidin will be captured.

You may qualify if:

• 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).

You may not qualify if:

• Enrollment in GPRD of less than one month duration.

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Impetigo

Interventions

retapamulin; Mupirocin; Fusidic Acid

Condition Hierarchy (Ancestors)

Staphylococcal Skin Infections; Staphylococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Streptococcal Infections; Skin Diseases, Bacterial; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Epoxy Compounds; Ethers, Cyclic; Ethers; Organic Chemicals; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fatty Acids; Lipids; Cholestadienols; Cholestadienes; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Membrane 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: May 13, 2010
• First Posted: June 30, 2010
• Study Start: November 1, 2008
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: June 10, 2013

Record last verified: 2013-05