Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Global Prevalence of Infections in Urology Study (GPIU)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03665467
Recruitment Status : Active, not recruiting
First Posted : September 11, 2018
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
Florian M E Wagenlehner, University of Giessen

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 Northern Institute for Cancer Research Newcastle University, UK

Dominic Althaus Software engineer Giessen (Ger)


Condition or disease
Hospital Infection Urinary Tract Infections

Layout table for study information
Study Type : Observational
Actual Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Global Prevalence of Infections in Urology Study
Actual Study Start Date : November 30, 2003
Actual Primary Completion Date : November 30, 2017
Estimated Study Completion Date : November 30, 2018



Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
-hospitalised urological patients
Criteria
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03665467


Locations
Layout table for location information
Germany
Giessen University, Medical School
Gießen, Germany
Hungary
Jahn Ferenc South Pest Teaching Hospital
Budapest, Hungary, 1204
Norway
Oslo University
Oslo, Norway
United Kingdom
Western General Hospital
Edinburgh, United Kingdom, EH9 1HN
Sponsors and Collaborators
European Association of Urology Research Foundation
Investigators
Layout table for investigator information
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

Additional Information:
Publications:

Layout table for additonal information
Responsible Party: Florian M E Wagenlehner, Professor of Urology, University of Giessen
ClinicalTrials.gov Identifier: NCT03665467     History of Changes
Other Study ID Numbers: GPIU
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Clinical Study Report (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.
URL: http://gpiu.esiu.org/

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Infection
Communicable Diseases
Urinary Tract Infections
Cross Infection
Urologic Diseases
Iatrogenic Disease
Disease Attributes
Pathologic Processes