Status: Finalised
First registered on:
25/01/2017
Last updated on:
25/01/2017
1. Study identification
EU PAS Register NumberEUPAS17402
Official titleBurden of Herpes Zoster in selected immunocompromised populations in the German Pharmacoepidemiological Research Database (GePaRD)
Study title acronym
Study typeObservational study
Brief description of the studyBased on data from statutory health insurance providers, the study investigates the incidence of herpes zoster in patients with different severities of immunosuppression. Besides, frequencies of complications and different aspects of healthcare resource utilisation are examined for herpes zoster patients stratified by severity of immunosuppression.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)?
Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsBIPS GmbH
Department/Research groupClinical Epidemiology
Organisation/affiliationLeibniz Inst. for Prevention Research and Epidem.
Details of (Primary) lead investigator
Title Dr
Last name Riedel
First name Oliver
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)
Countries in which this study is being conducted
National study
Germany
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed03/04/201501/06/2015
Start date of data collection20/07/201501/12/2015
Start date of data analysis10/08/201504/01/2016
Date of interim report, if expected
Date of final study report10/06/201630/11/2016
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesGlaxoSmithKline Biologicals S.A.100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Riedel
First name Oliver
Address line 1Achterstraße 30
Address line 2
Address line 3
CityBremen
Postcode28359
CountryGermany
Phone number (incl. country code)49-421-21856883
Alternative phone number
Fax number (incl. country code)
Public Enquiries
Title Dr
Last name Riedel
First name Oliver
Address line 1Achterstraße 30
Address line 2
Address line 3
CityBremen
Postcode28359
CountryGermany
Phone number (incl. country code)49-421-21856883
Alternative phone number
Fax number (incl. country code)
6. Study drug(s) information
Not applicable (disease/epidemiology study)
7. Medical conditions to be studied
Medical condition(s)Yes
Herpes zoster
8. Population under study
Age
Adults (18 - 44 years)
Adults (45 - 64 years)
Adults (65 - 74 years)
Adults (75 years and over)
Sex
Male
Female
9. Number of subjects
Estimated total number of subjects1260000
10. Source of data
Is this study being carried out with an established data source?Yes
Data sources registered with ENCePP
Sources of data
Administrative database, e.g. claims database
11. Scope of the study
What is the scope of the study?
Disease epidemiology
Primary scope : Disease epidemiology
12. Main objective(s)
What is the main objective of the study?
To estimate the incidence of herpes zoster and its complications in immunocompromised subjects, aged 18 years and above, overall and stratified by sex, age group, and type of immunocompromising disease or therapy.
Are there primary outcomes?Yes
Incidence of herpes zoster.
Are there secondary outcomes?Yes
Prevalence of herpes zoster complications and frequencies of hospitalisations, physician visits, and treatments with antivirals and analgesics.
13. Study design
What is the design of the study?
Cross-sectional study
Cohort study
14. Follow-up of patients
Will patients be followed up?Not applicable/no follow-up
15. Data analysis plan
Please provide a brief summary of the analysis method
A cross-sectional design will be used to identify patients with different severities of immunosuppression for the years 2006-2012 based on immunocompromising diseases and drug treatments. A cohort design will be used to calculate annual incidence rates of herpes zoster for the years 2006-2012, stratified by age, sex, and severity of immunosuppression and to analyse the prevalence of herpes zoster complications, physician visits, hospitalisations, and antiviral and analgesic treatments.
16. ENCePP seal
Are you requesting the ENCePP seal for this study?
No
17. Full protocol
Not submitted
18. Study Results
Not submitted
Please list the 5 most relevant publications using data from your study
ReferenceLink to web-publication
None
19. Other relevant documents
Conflict(s) of interest of
investigator(s)Not submitted
Composition of Steering Group and
ObserversNot submitted
Other documentsNot
submitted
Signed Code of
Conduct Checklist
Not submitted
Signed Code of Conduct Declaration
Not submitted
Signed Checklist for Study
Protocols
Not submitted
