NCT03665467

Brief 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. 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

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2003

Longer than P75 for all trials

Geographic Reach
4 countries

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 30, 2003

Completed
14.6 years until next milestone

First Submitted

Initial submission to the registry

July 8, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 11, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2021

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

February 4, 2021

Status Verified

February 1, 2021

Enrollment Period

17.2 years

First QC Date

July 8, 2018

Last Update Submit

February 2, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Health care associated infection episode

    Health Care Associated Infections per definition of the Center for Disease Control

    an infection onset 48 hours after admission to hospital or after an intervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (4)

Giessen University, Medical School

Giessen, Germany

RECRUITING

Jahn Ferenc South Pest Teaching Hospital

Budapest, 1204, Hungary

RECRUITING

Oslo University

Oslo, Norway

RECRUITING

University College London

London, United Kingdom

RECRUITING

Related Publications (7)

  • 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.

    PMID: 26797640BACKGROUND
  • 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.

    PMID: 28723463BACKGROUND
  • 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.

    PMID: 26658886BACKGROUND
  • 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.

    PMID: 24452449BACKGROUND
  • 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.

    PMID: 23979151BACKGROUND
  • 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.

    PMID: 23031676BACKGROUND
  • 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.

    PMID: 22704727BACKGROUND

MeSH Terms

Conditions

Cross InfectionUrinary Tract Infections

Condition Hierarchy (Ancestors)

InfectionsIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Florian Wagenlehner, Prof.

    Giessen University

    STUDY CHAIR
  • Zafer Tandogdu

    Mr

    PRINCIPAL INVESTIGATOR
  • Truls Erik Bjerklund Johansen, Prof.

    Oslo University

    STUDY DIRECTOR
  • Bela Koves, PhD

    Jahn Ferenc South Pest Teaching Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Urology

Study Record Dates

First Submitted

July 8, 2018

First Posted

September 11, 2018

Study Start

November 30, 2003

Primary Completion

January 31, 2021

Study Completion

December 31, 2021

Last Updated

February 4, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will share

* 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.

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
Annual
Access Criteria
Study investigators will be able to access their own data and in addition the summary statistics of the pooled sample on an annual basis.
More information

Locations