Hospital InfectionGPIUNCT03665467
The Global Prevalence of Infections in Urology Study
An observational study of Hospital Infection and Urinary Tract Infections, run by European Association of Urology Research Foundation at 4 sites in 4 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hospital Infection, Urinary Tract Infections
- How many people
- 2,000 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 30 Nov 2003to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: -hospitalised urological patients
- 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
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
Germany1 site, 1 recruiting
- Recruiting
Giessen University, Medical School
Giessen
Florian Wagenlehner, Prof, Florian.Wagenlehner@chiru.med.uni-giessen.de
Hungary1 site, 1 recruiting
- Recruiting
Jahn Ferenc South Pest Teaching Hospital
Budapest, 1204
Norway1 site, 1 recruiting
- Recruiting
Oslo University
Oslo
Truls Erik Bjerklund Johansen, t.e.b.johansen@medisin.uio.no
United Kingdom1 site, 1 recruiting
- Recruiting
University College London
London
Zafer Tandogdu, drzafer@gmail.com
About this study
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.
Read more
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
- Conditions
- Hospital Infection, Urinary Tract Infections
- Medical subject headings
- Cross Infection, Urinary Tract Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Health care associated infection episode
Health Care Associated Infections per definition of the Center for Disease Control
Measured: an infection onset 48 hours after admission to hospital or after an intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2018
- Study start30 Nov 2003
- Primary completion31 Jan 2021
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Hospital InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Association of Urology Research Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Florian M E Wagenlehner, University of Giessen
- Investigators
- Florian Wagenlehner, Prof., Study chair, Giessen UniversityZafer Tandogdu, Principal investigator, MrTruls Erik Bjerklund Johansen, Prof., Study director, Oslo UniversityBela Koves, PhD, Principal investigator, Jahn Ferenc South Pest Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03665467
- Sponsor's protocol ID
- GPIU
- Acronym
- GPIU
- Status last verified
- Feb 2021
- First submitted
- 8 Jul 2018
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: * 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.
Publications
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.
PubMed 26797640Wagenlehner 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.
PubMed 28723463Tandogdu 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.
PubMed 26658886Cek 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.
PubMed 24452449Tandogdu 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.
PubMed 23979151Cek 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.
PubMed 23031676Wagenlehner 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.
PubMed 22704727
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Global Prevalence of Infections in Urology Study
- ClinicalTrials.gov ID
- NCT03665467
- Acronym / sponsor ID
- GPIU / GPIU
- Conditions
- Hospital Infection, Urinary Tract Infections
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- European Association of Urology Research FoundationUniversity, hospital or other
- Study start
- 30 Nov 2003 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 11 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- -hospitalised urological patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Health care associated infection episode
Time frame: an infection onset 48 hours after admission to hospital or after an intervention
Health Care Associated Infections per definition of the Center for Disease Control
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
- Background: PubMed 26797640Wagenlehner 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.
- Background: PubMed 28723463Wagenlehner 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.
- Background: PubMed 26658886Tandogdu 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.
- Background: PubMed 24452449Cek 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.
- Background: PubMed 23979151Tandogdu 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.
- Background: PubMed 23031676Cek 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.
- Background: PubMed 22704727Wagenlehner 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.
- Individual participant dataSharing planned: Yes. * 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florian Wagenlehner, Prof. study chair
Giessen University
Zafer Tandogdu principal investigator
Mr
Truls Erik Bjerklund Johansen, Prof. study director
Oslo University
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hospital Infection and Urinary Tract Infections, run by European Association of Urology Research Foundation at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany, Hungary, Norway, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Florian Wagenlehner, Prof (+4916096018166, Florian.Wagenlehner@chiru.med.uni-giessen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health care associated infection episode (time frame: an infection onset 48 hours after admission to hospital or after an intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03665467, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2021.