Study to Assess Management and Outcomes of Hospitalised Patients With Complicated UTI (RESCUING)
NCT ID: NCT02641015
Last Updated: 2017-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
1028 participants
OBSERVATIONAL
2015-12-31
2016-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
POS-cUTI: Study on Complicated Urinary Tract Infections
NCT05458700
Study of E. Coli Isolates From Recurrent Urinary Tract Infections
NCT05826067
Urinary Tract Infection in Patients With Chronic Kidney Disease
NCT05674942
Safety and Efficacy of IV CXA-101 and IV Ceftazidime in Patients With Complicated Urinary Tract Infections
NCT00921024
Diagnosis of Subclinical Urinary Tract Infections Using Advanced Microbiome Survey Techniques in High Risk Trauma Patients
NCT01834391
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The overall aim of this study is to provide information about the epidemiology, clinical management and outcome of patients hospitalised with cUTI, including pyelonephritis. To achieve this aim, the investigators will perform a multicentre retrospective observational study in patients with hospitalised cUTI. The study will be conducted in several European countries plus Israel, which have a high prevalence of MDR Gram-negative bacteria (GNB), including Pseudomonas aeruginosa. The study will seek to identify possible modifiable risk factors for treatment failure, especially those related to antibiotic therapy.
On completion of this study, the investigators will develop a better understanding of the clinical management of hospitalised patients with cUTI due to MDR GNB in European countries. The investigators will identify the modifiable risk factors for treatment failure. This information will be used to inform better clinical and antibiotic management of cUTI to improve patient outcomes. The study will also be used in the development of hypothesis for future randomised controlled trials in cUTI with new antibiotics. Dissemination of results will take place through peer-reviewed publications and conference presentations.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
RETROSPECTIVE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Indwelling urinary catheter
* Urinary retention (at least 100ml of residual urine after voiding)
* Neurogenic bladder
* Obstructive uropathy (e.g. nephrolithiasis, fibrosis)
* Renal impairment caused by intrinsic renal disease: Estimated glomerular filtration rate (eGFR) \<60 mL/min
* Renal transplantation
* Urinary tract modifications, such as an ileal loop or pouch
* Pyelonephritis and normal urinary tract anatomy
and at least one of the following signs or symptoms:
* Chills or rigors associated with fever or hypothermia (temperature greater than 38ºC or below 36ºC)
* Flank pain (pyelonephritis) or pelvic pain (cUTI)
* Dysuria, urinary frequency, or urinary urgency
* Costo-vertebral angle tenderness on physical examination
* UTI-related altered mental state
and at least one of the following microbiological results:
* Urine culture with at least 105 CFU/mL or greater of a uropathogen (no more than 2 species)
* At least one blood culture growing possible uropathogens (no more than 2 species) with no other evident site of infection
Exclusion Criteria
* Prostatitis
* Polymicrobial infections that include Candida spp.
* Polymicrobial infections that include more than 2 bacterial species
* cUTI with Candida spp. as sole uropathogen
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Tel Aviv University
OTHER
AiCuris Anti-infective Cures AG
INDUSTRY
University of Bristol
OTHER
UMC Utrecht
OTHER
Institut d'Investigació Biomèdica de Bellvitge
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Miquel Pujol
PhD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Dora Tancheva, Mrs
Role: PRINCIPAL_INVESTIGATOR
Emergency Hospital Pirogov, Sofia, Bulgaria
Rossitza Vatcheva-Dobrevska, Prof
Role: PRINCIPAL_INVESTIGATOR
University Hospital Queen Joanna, Sofia, Bulgaria
Sotirios Tsiodras, Prof
Role: PRINCIPAL_INVESTIGATOR
Attikon University Hospital, Athens, Greece
Emmanuel Roilides, Prof
Role: PRINCIPAL_INVESTIGATOR
Hippokration Hospital, Thessaloniki, Greece
Istvan Vakonyi, MD
Role: PRINCIPAL_INVESTIGATOR
Kenezy University Hospital,Debrecen, Hungary
Aniko Farkas, MD
Role: PRINCIPAL_INVESTIGATOR
Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház (SZSZBMK). Nyíregyháza, Hungary
Leonard Leibovici, Prof
Role: PRINCIPAL_INVESTIGATOR
Beilinson Hospital, Rabin Medical Center. Petah-TiqvaI, Israel
Mical Paul, Prof
Role: PRINCIPAL_INVESTIGATOR
Rambam Health Care Campus. Haifa, Israel
Yehuda Carmeli, Prof
Role: PRINCIPAL_INVESTIGATOR
Tel Aviv Medical Center, Tel Aviv. Israel
Emanuele Durante Mangoni, Prof
Role: PRINCIPAL_INVESTIGATOR
AORN dei Colli Monaldi. Napoli, Italy
Erica Franceschini, MD
Role: PRINCIPAL_INVESTIGATOR
Azienda ospedaliero-universitaria policlinico di modena, Modena, Italy
Nicola Petrosillo, MD
Role: PRINCIPAL_INVESTIGATOR
National Institute for Infectious Diseases L. Spallanzani, IRCCS, Rome, Italy
Andrei Ursache, MD
Role: PRINCIPAL_INVESTIGATOR
"Spitalul Clinic de Urgenta Bucuresti. Popular unoficial name ""Floreasca "" Hospital", Bucharest, Romania
Judit Bodnár, MD
Role: PRINCIPAL_INVESTIGATOR
Soproni Erzsébet Oktató Kórház és Rehabilitációs Intézet, Sopron, Hungary
Yehuda Carmeli, Prof
Role: PRINCIPAL_INVESTIGATOR
Tel Aviv Medical Center, Tel Aviv, Israel
Andrei Vata, MD
Role: PRINCIPAL_INVESTIGATOR
Infectious Diseases Hospital Sfanta Parascheva Iasi, Iasi, Romania
Adriana Hristea, MD
Role: PRINCIPAL_INVESTIGATOR
National Institute for Infectious Diseases Prof Dr Matei Bals, Bucharest, Romania
Jesus Rodriguez-Bano, Prof
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario Virgen Macarena, Seville, Spain
Julia Origüen, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario 12 de Octubre, Madrid, Spain
Arzu Yetkin, MD
Role: PRINCIPAL_INVESTIGATOR
Ankara Numune Egitim ve ArastÄrma Hastanesi, Ankara, Turkey
Nese Saltoglu, Prof
Role: PRINCIPAL_INVESTIGATOR
Istanbul University Cerrahpasa Medical School, Istambul, Turkey
Miquel Pujol, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitari de Bellvitge, Barcelona, Spain
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Emergency Hospital Pirogov
Sofia, , Bulgaria
University Hospital Queen Joanna
Sofia, , Bulgaria
Attikon University Hospital
Athens, , Greece
Hippokration Hospital
Thessaloniki, , Greece
Kenezy University Hospital
Debrecen, , Hungary
Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház (SZSZBMK)
Nyíregyháza, , Hungary
Soproni Erzsébet Oktató Kórház és Rehabilitációs Intézet
Sopron, , Hungary
Rambam Health Care Campus
Haifa, , Israel
Beilinson Hospital, Rabin Medical Center
Petah Tikva, , Israel
Tel Aviv Medical Center
Tel Aviv, , Israel
Azienda Ospedaliero-Universitaria Policlinico Di Modena
Modena, , Italy
AORN dei Colli Monaldi
Napoli, , Italy
National Institute for Infectious Diseases L. Spallanzani, IRCCS
Rome, , Italy
"Spitalul Clinic de Urgenta Bucuresti. Popular unoficial name ""Floreasca "" Hospital"
Bucharest, , Romania
National Institute for Infectious Diseases Prof Dr Matei Bals
Bucharest, , Romania
Infectious Diseases Hospital Sfanta Parascheva Iasi
Iași, , Romania
Hospital Universitari de Bellvitge
L'Hospitalet Del Llobregat, Barcelona, Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Ankara Numune Egitim ve Arastırma Hastanesi
Ankara, , Turkey (Türkiye)
Istanbul University Cerrahpasa Medical School
Istanbul, , Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Morrissey I, Hackel M, Badal R, Bouchillon S, Hawser S, Biedenbach D. A Review of Ten Years of the Study for Monitoring Antimicrobial Resistance Trends (SMART) from 2002 to 2011. Pharmaceuticals (Basel). 2013 Nov 1;6(11):1335-46. doi: 10.3390/ph6111335.
Hoban DJ, Lascols C, Nicolle LE, Badal R, Bouchillon S, Hackel M, Hawser S. Antimicrobial susceptibility of Enterobacteriaceae, including molecular characterization of extended-spectrum beta-lactamase-producing species, in urinary tract isolates from hospitalized patients in North America and Europe: results from the SMART study 2009-2010. Diagn Microbiol Infect Dis. 2012 Sep;74(1):62-7. doi: 10.1016/j.diagmicrobio.2012.05.024. Epub 2012 Jul 2.
Yang YS, Ku CH, Lin JC, Shang ST, Chiu CH, Yeh KM, Lin CC, Chang FY. Impact of Extended-spectrum beta-lactamase-producing Escherichia coli and Klebsiella pneumoniae on the outcome of community-onset bacteremic urinary tract infections. J Microbiol Immunol Infect. 2010 Jun;43(3):194-9. doi: 10.1016/S1684-1182(10)60031-X.
Ha YE, Kang CI, Cha MK, Park SY, Wi YM, Chung DR, Peck KR, Lee NY, Song JH. Epidemiology and clinical outcomes of bloodstream infections caused by extended-spectrum beta-lactamase-producing Escherichia coli in patients with cancer. Int J Antimicrob Agents. 2013 Nov;42(5):403-9. doi: 10.1016/j.ijantimicag.2013.07.018. Epub 2013 Sep 7.
Trecarichi EM, Tumbarello M. Antimicrobial-resistant Gram-negative bacteria in febrile neutropenic patients with cancer: current epidemiology and clinical impact. Curr Opin Infect Dis. 2014 Apr;27(2):200-10. doi: 10.1097/QCO.0000000000000038.
Kumar A, Ellis P, Arabi Y, Roberts D, Light B, Parrillo JE, Dodek P, Wood G, Kumar A, Simon D, Peters C, Ahsan M, Chateau D; Cooperative Antimicrobial Therapy of Septic Shock Database Research Group. Initiation of inappropriate antimicrobial therapy results in a fivefold reduction of survival in human septic shock. Chest. 2009 Nov;136(5):1237-1248. doi: 10.1378/chest.09-0087. Epub 2009 Aug 20.
Spoorenberg V, Hulscher ME, Akkermans RP, Prins JM, Geerlings SE. Appropriate antibiotic use for patients with urinary tract infections reduces length of hospital stay. Clin Infect Dis. 2014 Jan;58(2):164-9. doi: 10.1093/cid/cit688. Epub 2013 Oct 24.
Levison ME, Kaye D. Treatment of complicated urinary tract infections with an emphasis on drug-resistant gram-negative uropathogens. Curr Infect Dis Rep. 2013 Apr;15(2):109-15. doi: 10.1007/s11908-013-0315-7.
Nicolle LE. A practical guide to the management of complicated urinary tract infection. Drugs. 1997 Apr;53(4):583-92. doi: 10.2165/00003495-199753040-00004.
Foxman B. Epidemiology of urinary tract infections: incidence, morbidity, and economic costs. Am J Med. 2002 Jul 8;113 Suppl 1A:5S-13S. doi: 10.1016/s0002-9343(02)01054-9.
Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.
Karnofsky DA, Burchenal JH: The clinical evaluation of chemotherapeutic agents in cancer. In Evaluation of chemotherapeutic agents. Edited by MacLeod CM. New York: Columbia University Press; 1949:191-205.
Barber J, Thompson S. Multiple regression of cost data: use of generalised linear models. J Health Serv Res Policy. 2004 Oct;9(4):197-204. doi: 10.1258/1355819042250249.
Magiorakos AP, Srinivasan A, Carey RB, Carmeli Y, Falagas ME, Giske CG, Harbarth S, Hindler JF, Kahlmeter G, Olsson-Liljequist B, Paterson DL, Rice LB, Stelling J, Struelens MJ, Vatopoulos A, Weber JT, Monnet DL. Multidrug-resistant, extensively drug-resistant and pandrug-resistant bacteria: an international expert proposal for interim standard definitions for acquired resistance. Clin Microbiol Infect. 2012 Mar;18(3):268-81. doi: 10.1111/j.1469-0691.2011.03570.x. Epub 2011 Jul 27.
Shaw E, Addy I, Stoddart M, Vank C, Grier S, Wiegand I, Leibovici L, Eliakim-Raz N, Vallejo-Torres L, Morris S, MacGowan A, Carratala J, Pujol M; COMBACTE-MAGNET Consortium. Retrospective observational study to assess the clinical management and outcomes of hospitalised patients with complicated urinary tract infection in countries with high prevalence of multidrug resistant Gram-negative bacteria (RESCUING). BMJ Open. 2016 Jul 29;6(7):e011500. doi: 10.1136/bmjopen-2016-011500.
Related Links
Access external resources that provide additional context or updates about the study.
UK Five Year Antimicrobial Resistance Strategy 2013-2018, September 2013.
The European Union Summary Report on antimicrobial resistance in zoonotic and indicator bacteria from humans, animals and food in 2012
Complicated Urinary Tract Infections: Developing Drugs for Treatment. Guidance for Industry (2015). U.S. Department of Health and Human Services, Food and Drug Administration Center for Drug Evaluation and Research (CDER).
International Classification of Diseases ICD-9 Data.
International Statistical Classification of diseases and related Health Problems 10th Revision. ICD-10. Version 2015.
University of Maryland Medical Center. Urinary tract Infection
Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PR 223/15
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.