Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2026-02-02 @ 2:10 AM
Study NCT ID:
NCT03665467
Status:
UNKNOWN
Last Update Posted:
2021-02-04
First Post:
2018-07-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Global Prevalence of Infections in Urology Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003428', 'term': 'Cross Infection'}, {'id': 'D014552', 'term': 'Urinary Tract Infections'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D007049', 'term': 'Iatrogenic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2003-11-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-02', 'studyFirstSubmitDate': '2018-07-08', 'studyFirstSubmitQcDate': '2018-09-08', 'lastUpdatePostDateStruct': {'date': '2021-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Health care associated infection episode', 'timeFrame': 'an infection onset 48 hours after admission to hospital or after an intervention', 'description': 'Health Care Associated Infections per definition of the Center for Disease Control'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hospital Infection', 'Urinary Tract Infections']}, 'referencesModule': {'references': [{'pmid': '26797640', 'type': 'BACKGROUND', 'citation': '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': '28723463', 'type': 'BACKGROUND', 'citation': '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': '26658886', 'type': 'BACKGROUND', 'citation': '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': '24452449', 'type': 'BACKGROUND', 'citation': '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': '23979151', 'type': 'BACKGROUND', 'citation': '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': '23031676', 'type': 'BACKGROUND', 'citation': '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': '22704727', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nWhy? 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.\n\nTake responsibility for the future of urology - join the GPIU-studies! http://gpiu.esiu.org\n\nProf. Dr. Florian M.E. Wagenlehner, MD, PhD Clinic for Urology, Pediatric Urology and Andrology University Clinic Giessen, Germany GPIU study coordinator\n\nProf. Truls E. Bjerklund Johansen, MD, PhD Urology Department, Oslo University Hospital, Chairman ESIU Oslo, NO GPIU Study coordinator\n\nZafer Tandogdu University College London (UCL), UK\n\nDominic Althaus Software engineer Giessen, Ger'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '-hospitalised urological patients', 'healthyVolunteers': False, 'eligibilityCriteria': '* On the chosen single study day at 08:00 AM local time all patients present on the ward of the participating institution are included\n* 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\n* 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'}, 'identificationModule': {'nctId': 'NCT03665467', 'acronym': 'GPIU', 'briefTitle': 'The Global Prevalence of Infections in Urology Study', 'organization': {'class': 'OTHER', 'fullName': 'European Association of Urology Research Foundation'}, 'officialTitle': 'The Global Prevalence of Infections in Urology Study', 'orgStudyIdInfo': {'id': 'GPIU'}}, 'contactsLocationsModule': {'locations': [{'city': 'Giessen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Florian Wagenlehner, Prof', 'role': 'CONTACT', 'email': 'Florian.Wagenlehner@chiru.med.uni-giessen.de'}], 'facility': 'Giessen University, Medical School', 'geoPoint': {'lat': 50.58727, 'lon': 8.67554}}, {'zip': '1204', 'city': 'Budapest', 'status': 'RECRUITING', 'country': 'Hungary', 'facility': 'Jahn Ferenc South Pest Teaching Hospital', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'city': 'Oslo', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Truls Erik Bjerklund Johansen', 'role': 'CONTACT', 'email': 't.e.b.johansen@medisin.uio.no'}], 'facility': 'Oslo University', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Zafer Tandogdu', 'role': 'CONTACT', 'email': 'drzafer@gmail.com'}], 'facility': 'University College London', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Florian Wagenlehner, Prof', 'role': 'CONTACT', 'email': 'Florian.Wagenlehner@chiru.med.uni-giessen.de', 'phone': '+4916096018166'}, {'name': 'Zafer Tandogdu, MD', 'role': 'CONTACT', 'email': 'drzafer@gmail.com', 'phone': '07477473347'}], 'overallOfficials': [{'name': 'Florian Wagenlehner, Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Giessen University'}, {'name': 'Zafer Tandogdu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mr'}, {'name': 'Truls Erik Bjerklund Johansen, Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Oslo University'}, {'name': 'Bela Koves, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jahn Ferenc South Pest Teaching Hospital'}]}, 'ipdSharingStatementModule': {'url': 'http://gpiu.esiu.org/', 'infoTypes': ['STUDY_PROTOCOL', 'CSR'], 'timeFrame': 'Annual', 'ipdSharing': 'YES', 'description': '* Investigators will be able to download their own submitted data\n* Investigators will be able to access an online summary statistics of the annual pooled sample\n* Investigators will be able to compare their own summary statistics with other centers on the study website.', 'accessCriteria': 'Study investigators will be able to access their own data and in addition the summary statistics of the pooled sample on an annual basis.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Association of Urology Research Foundation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Urology', 'investigatorFullName': 'Florian M E Wagenlehner', 'investigatorAffiliation': 'University of Giessen'}}}}