- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03665467
The Global Prevalence of Infections in Urology Study (GPIU)
Urology departments from all over the world are invited to join the Global Prevalence Study on Infections in Urology (GPIU-study) and the GPIU Prostate Biopsy Side Study. The GPIU study is taking part annually in November since 2003. European urologists were the first group of specialist to register hospital acquired infections on an international level. More than 20.000 patients have been screened and more than 2000 patients are currently listed in this database.
Why? Infectious complications after urological procedures, such as prostate biopsy and increasing antimicrobial resistance are posing significant threats to modern urology The GPIU-study is a combined quality improvement initiative and a scientific study. Once the participating departments have filled in the report forms they will get access to statistics showing the accumulated results for all participating hospitals. The participants can anonymously compare their own results with hospitals from all over the World. The GPIU-study application has been designed as an instrument to ongoing follow-up of the development of important factors related to infection on international, national and local levels.
Take responsibility for the future of urology - join the GPIU-studies! http://gpiu.esiu.org
Prof. Dr. Florian M.E. Wagenlehner, MD, PhD Clinic for Urology, Pediatric Urology and Andrology University Clinic Giessen, Germany GPIU study coordinator
Prof. Truls E. Bjerklund Johansen, MD, PhD Urology Department, Oslo University Hospital, Chairman ESIU Oslo, NO GPIU Study coordinator
Zafer Tandogdu University College London (UCL), UK
Dominic Althaus Software engineer Giessen, Ger
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Gießen, Germany
- Recruiting
- Giessen University, Medical School
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Contact:
- Florian Wagenlehner, Prof
- Email: Florian.Wagenlehner@chiru.med.uni-giessen.de
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Budapest, Hungary, 1204
- Recruiting
- Jahn Ferenc South Pest Teaching Hospital
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Oslo, Norway
- Recruiting
- Oslo University
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Contact:
- Truls Erik Bjerklund Johansen
- Email: t.e.b.johansen@medisin.uio.no
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London, United Kingdom
- Recruiting
- University College London
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Contact:
- Zafer Tandogdu
- Email: drzafer@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
- On the chosen single study day at 08:00 AM local time all patients present on the ward of the participating institution are included
- The presence of urinary tract infections (UTI) according to the CDC definitions during their entire hospital stay are documented and audited and the patients are categorized as having or not having a UTI and/or
- The presence of surgical site infection (SSI) according to the CDC definitions during their entire hospital stay are documented and audited and the patients are categorized as having or not having a SSI
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Health care associated infection episode
Time Frame: an infection onset 48 hours after admission to hospital or after an intervention
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Health Care Associated Infections per definition of the Center for Disease Control
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an infection onset 48 hours after admission to hospital or after an intervention
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Collaborators and Investigators
Investigators
- Study Chair: Florian Wagenlehner, Prof., Giessen University
- Principal Investigator: Zafer Tandogdu, Mr
- Study Director: Truls Erik Bjerklund Johansen, Prof., Oslo University
- Principal Investigator: Bela Koves, PhD, Jahn Ferenc South Pest Teaching Hospital
Publications and helpful links
General Publications
- Tandogdu Z, Cek M, Wagenlehner F, Naber K, Tenke P, van Ostrum E, Johansen TB. Resistance patterns of nosocomial urinary tract infections in urology departments: 8-year results of the global prevalence of infections in urology study. World J Urol. 2014 Jun;32(3):791-801. doi: 10.1007/s00345-013-1154-8. Epub 2013 Aug 24.
- Wagenlehner F, Tandogdu Z, Bartoletti R, Cai T, Cek M, Kulchavenya E, Koves B, Naber K, Perepanova T, Tenke P, Wullt B, Bogenhard F, Johansen TE. The Global Prevalence of Infections in Urology Study: A Long-Term, Worldwide Surveillance Study on Urological Infections. Pathogens. 2016 Jan 19;5(1):10. doi: 10.3390/pathogens5010010.
- Wagenlehner F, Tandogdu Z, Bartoletti R, Cai T, Cek M, Kulchavenya E, Koves B, Naber K, Perepanova T, Tenke P, Wullt B, Bogenhard F, Bjerklund Johansen TE; GPIU Investigators. The Global Prevalence of Infections in Urology (GPUI) Study: A Worldwide Surveillance Study in Urology Patients. Eur Urol Focus. 2016 Oct;2(4):345-347. doi: 10.1016/j.euf.2016.03.004. Epub 2016 Apr 1.
- Tandogdu Z, Bartoletti R, Cai T, Cek M, Grabe M, Kulchavenya E, Koves B, Menon V, Naber K, Perepanova T, Tenke P, Wullt B, Johansen TE, Wagenlehner F. Antimicrobial resistance in urosepsis: outcomes from the multinational, multicenter global prevalence of infections in urology (GPIU) study 2003-2013. World J Urol. 2016 Aug;34(8):1193-200. doi: 10.1007/s00345-015-1722-1. Epub 2015 Dec 11.
- Cek M, Tandogdu Z, Wagenlehner F, Tenke P, Naber K, Bjerklund-Johansen TE. Healthcare-associated urinary tract infections in hospitalized urological patients--a global perspective: results from the GPIU studies 2003-2010. World J Urol. 2014 Dec;32(6):1587-94. doi: 10.1007/s00345-013-1218-9. Epub 2014 Jan 23.
- Cek M, Tandogdu Z, Naber K, Tenke P, Wagenlehner F, van Oostrum E, Kristensen B, Bjerklund Johansen TE; Global Prevalence Study of Infections in Urology Investigators. Antibiotic prophylaxis in urology departments, 2005-2010. Eur Urol. 2013 Feb;63(2):386-94. doi: 10.1016/j.eururo.2012.09.038. Epub 2012 Sep 25.
- Wagenlehner FM, van Oostrum E, Tenke P, Tandogdu Z, Cek M, Grabe M, Wullt B, Pickard R, Naber KG, Pilatz A, Weidner W, Bjerklund-Johansen TE; GPIU investigators. Infective complications after prostate biopsy: outcome of the Global Prevalence Study of Infections in Urology (GPIU) 2010 and 2011, a prospective multinational multicentre prostate biopsy study. Eur Urol. 2013 Mar;63(3):521-7. doi: 10.1016/j.eururo.2012.06.003. Epub 2012 Jun 12.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GPIU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
- Investigators will be able to download their own submitted data
- Investigators will be able to access an online summary statistics of the annual pooled sample
- Investigators will be able to compare their own summary statistics with other centers on the study website.
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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