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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

Tracking Information
First Submitted Date July 8, 2018
First Posted Date September 11, 2018
Last Update Posted Date September 11, 2018
Actual Study Start Date November 30, 2003
Actual Primary Completion Date November 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 8, 2018)
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Global Prevalence of Infections in Urology Study
Official Title The Global Prevalence of Infections in Urology Study
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)

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population -hospitalised urological patients
Condition
  • Hospital Infection
  • Urinary Tract Infections
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: September 8, 2018)
2000
Original Actual Enrollment Same as current
Estimated Study Completion Date November 30, 2018
Actual Primary Completion Date November 30, 2017   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany,   Hungary,   Norway,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT03665467
Other Study ID Numbers GPIU
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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
Supporting Materials: 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/
Responsible Party Florian M E Wagenlehner, University of Giessen
Study Sponsor European Association of Urology Research Foundation
Collaborators Not Provided
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
PRS Account European Association of Urology Research Foundation
Verification Date September 2018