EU PV for Retapamulin-Prescribing - Full Text View

Purpose

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.

Condition	Intervention
Impetigo	Drug: Retapamulin Drug: Co-prescription of retapamulin and topical mupirocin Drug: Co-prescription of retapamulin and topical fusidic acid

Study Type:	Observational
Study Design:	Time Perspective: Retrospective
Official Title:	Pharmacovigilence for Retapamulin: Age-stratified Monitoring of Prescribed Use in the European Union

Resource links provided by NLM:

MedlinePlus related topics: Impetigo

Drug Information available for: Mupirocin Mupirocin calcium Retapamulin

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Prescription for retapamulin [ Time Frame: First prescription in database for each calendar year between January 2007 and December 2011 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Co-prescription of retapamulin and topical mupirocin [ Time Frame: First same-day prescriptions for both medicines in database for each calendar year between January 2007 and December 2011 ] [ Designated as safety issue: Yes ]
Co-prescription of retapamulin and topical fusidic acid [ Time Frame: First same-day prescriptons for both medicines in database for each calendar year between January 2007 and December 2011 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	1
Study Start Date:	November 2008
Estimated Study Completion Date:	October 2012
Estimated Primary Completion Date:	October 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
(1) Age <9 months Age at time of prescription was <9 months	Drug: Retapamulin Prescription for retapamulin Drug: Co-prescription of retapamulin and topical mupirocin Same day prescriptions for retapamulin and topical mupirocin Drug: Co-prescription of retapamulin and topical fusidic acid Same day prescription for retapamulin and fusidic acid.
(2) 9 months to 6 years Age at time of prescription was 9 months to 6 years	Drug: Retapamulin Prescription for retapamulin Drug: Co-prescription of retapamulin and topical mupirocin Same day prescriptions for retapamulin and topical mupirocin Drug: Co-prescription of retapamulin and topical fusidic acid Same day prescription for retapamulin and fusidic acid.
(3) 7 years to 18 years Age at time of prescription was 7 years to 18 years	Drug: Retapamulin Prescription for retapamulin Drug: Co-prescription of retapamulin and topical mupirocin Same day prescriptions for retapamulin and topical mupirocin Drug: Co-prescription of retapamulin and topical fusidic acid Same day prescription for retapamulin and fusidic acid.
(4) 19 to 65 years Age at time of prescription was 19 to 65 years	Drug: Retapamulin Prescription for retapamulin Drug: Co-prescription of retapamulin and topical mupirocin Same day prescriptions for retapamulin and topical mupirocin Drug: Co-prescription of retapamulin and topical fusidic acid Same day prescription for retapamulin and fusidic acid.
(5) 66 years and older Age at time of prescription was 66 years and older	Drug: Retapamulin Prescription for retapamulin Drug: Co-prescription of retapamulin and topical mupirocin Same day prescriptions for retapamulin and topical mupirocin Drug: Co-prescription of retapamulin and topical fusidic acid Same day prescription for retapamulin and fusidic acid.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
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.

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01153828

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT01153828 History of Changes
Other Study ID Numbers:	113149
Study First Received:	May 13, 2010
Last Updated:	April 23, 2012
Health Authority:	United States: No Health Authority

Keywords provided by GlaxoSmithKline:

Altargo
Bactroban
Fucidin
Fusidic acid

Mupirocin
topical
Retapamulin
United Kingdom

Additional relevant MeSH terms:

Impetigo
Staphylococcal Skin Infections
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Streptococcal Infections
Skin Diseases, Bacterial
Skin Diseases, Infectious
Infection
Skin Diseases

Fusidic Acid
Mupirocin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013