Pharmacovigilence for Retapamulin: Age-stratified Monitoring of Prescribed Use in the European Union
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1
- 主要终点
- Prescription for retapamulin
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •Enrollment in GPRD of less than one month duration.
研究组 & 干预措施
(1) Age <9 months
Age at time of prescription was <9 months
干预措施: Retapamulin (Drug)
(1) Age <9 months
Age at time of prescription was <9 months
干预措施: Co-prescription of retapamulin and topical mupirocin (Drug)
(1) Age <9 months
Age at time of prescription was <9 months
干预措施: Co-prescription of retapamulin and topical fusidic acid (Drug)
(2) 9 months to 6 years
Age at time of prescription was 9 months to 6 years
干预措施: Retapamulin (Drug)
(2) 9 months to 6 years
Age at time of prescription was 9 months to 6 years
干预措施: Co-prescription of retapamulin and topical mupirocin (Drug)
(2) 9 months to 6 years
Age at time of prescription was 9 months to 6 years
干预措施: Co-prescription of retapamulin and topical fusidic acid (Drug)
(3) 7 years to 18 years
Age at time of prescription was 7 years to 18 years
干预措施: Retapamulin (Drug)
(3) 7 years to 18 years
Age at time of prescription was 7 years to 18 years
干预措施: Co-prescription of retapamulin and topical mupirocin (Drug)
(3) 7 years to 18 years
Age at time of prescription was 7 years to 18 years
干预措施: Co-prescription of retapamulin and topical fusidic acid (Drug)
(4) 19 to 65 years
Age at time of prescription was 19 to 65 years
干预措施: Retapamulin (Drug)
(4) 19 to 65 years
Age at time of prescription was 19 to 65 years
干预措施: Co-prescription of retapamulin and topical mupirocin (Drug)
(4) 19 to 65 years
Age at time of prescription was 19 to 65 years
干预措施: Co-prescription of retapamulin and topical fusidic acid (Drug)
(5) 66 years and older
Age at time of prescription was 66 years and older
干预措施: Retapamulin (Drug)
(5) 66 years and older
Age at time of prescription was 66 years and older
干预措施: Co-prescription of retapamulin and topical mupirocin (Drug)
(5) 66 years and older
Age at time of prescription was 66 years and older
干预措施: Co-prescription of retapamulin and topical fusidic acid (Drug)
结局指标
主要结局
Prescription for retapamulin
时间窗: First prescription in database for each calendar year between January 2007 and December 2011
次要结局
- 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)