Study to Assess Management and Outcomes of Hospitalised Patients With Complicated UTI (RESCUING)

NCT02641015 | Completed DMC

• 1 other identifier: PR 223/15
• Study Type: observational
• Target: 1,028
• Locations: 8 countries
• Sites: 21

Brief Summary

A 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 (COMBACTE-MAGNET,WP5)

Conditions

Urinary Tract Infections; Bacterial Resistance

Keywords

UTI

Outcome Measures

Primary Outcomes (1)

• Treatment Failure

  Treatment failure will be assessed as number of participants with evidence of treatment failure or mortality within 30 days from initial cUTI diagnosis

  30 days

Secondary Outcomes (11)

• Time to clinical response

  30 days

• Time to urological intervention for source control

  30 days

• Time to death

  30 days

• Duration of antibiotic therapy

  30 days

• Length of hospital stay

  30 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospitalised patients from 1st January 2013 to the 31st December 2014. Diagnosis of cUTI as the primary cause of hospitalisation and patients hospitalised for another reason but who developed cUTI during their hospitalisation. Patients will be identified by searching for any of the following ICD-9 CM or ICD-10 CM codes at discharge on the hospital administration system: ICD-9 CM Codes: 590.1, 590.10, 590.11, 590.2, 590.8, 590.80, 590.9, 595.0, 595.89, 595.9, 99.0 ICD-10 CM Codes: N10, N12, N13.6, N15.1, N15.9, N30.0, N30.8, N30.9, N39.0

You may qualify if:

• Patients with UTI and at least one of the following underlying conditions:
• 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

You may not qualify if:

• Patients less than 18 years of age
• Prostatitis
• Polymicrobial infections that include Candida spp.
• Polymicrobial infections that include more than 2 bacterial species
• cUTI with Candida spp. as sole uropathogen

Sponsors & Collaborators

• Institut d'Investigació Biomèdica de Bellvitge: lead
• Tel Aviv University: collaborator
• AiCuris Anti-infective Cures AG: collaborator
• University of Bristol: collaborator
• UMC Utrecht: collaborator

Study Sites (21)

Emergency Hospital Pirogov

Sofia, Bulgaria

Location

University Hospital Queen Joanna

Sofia, Bulgaria

Location

Attikon University Hospital

Athens, Greece

Location

Hippokration Hospital

Thessaloniki, Greece

Location

Kenezy University Hospital

Debrecen, Hungary

Location

Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház (SZSZBMK)

Nyíregyháza, Hungary

Location

Soproni Erzsébet Oktató Kórház és Rehabilitációs Intézet

Sopron, Hungary

Location

Rambam Health Care Campus

Haifa, Israel

Location

Beilinson Hospital, Rabin Medical Center

Petah Tikva, Israel

Location

Tel Aviv Medical Center

Tel Aviv, Israel

Location

Azienda Ospedaliero-Universitaria Policlinico Di Modena

Modena, Italy

Location

AORN dei Colli Monaldi

Napoli, Italy

Location

National Institute for Infectious Diseases L. Spallanzani, IRCCS

Rome, Italy

Location

"Spitalul Clinic de Urgenta Bucuresti. Popular unoficial name ""Floreasca "" Hospital"

Bucharest, Romania

Location

National Institute for Infectious Diseases Prof Dr Matei Bals

Bucharest, Romania

Location

Infectious Diseases Hospital Sfanta Parascheva Iasi

Iași, Romania

Location

Hospital Universitari de Bellvitge

L'Hospitalet Del Llobregat, Barcelona, 08907, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, Spain

Location

Hospital Universitario Virgen Macarena

Seville, Spain

Location

Ankara Numune Egitim ve Arastırma Hastanesi

Ankara, Turkey (Türkiye)

Location

Istanbul University Cerrahpasa Medical School

Istanbul, Turkey (Türkiye)

Location

Related Publications (15)

• 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.

  PMID: 24287460 BACKGROUND

• 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.

  PMID: 22763019 BACKGROUND

• 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.

  PMID: 21291846 BACKGROUND

• 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.

  PMID: 24071027 BACKGROUND

• 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.

  PMID: 24573013 BACKGROUND

• 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.

  PMID: 19696123 BACKGROUND

• 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.

  PMID: 24158412 BACKGROUND

• 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.

  PMID: 23378123 BACKGROUND

• 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.

  PMID: 9098661 BACKGROUND

• 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.

  PMID: 12113866 BACKGROUND

• 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.

  PMID: 3558716 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 15509405 BACKGROUND

• 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.

  PMID: 21793988 BACKGROUND

• 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.

  PMID: 27473949 DERIVED

Related Links

• 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

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Dora Tancheva, Mrs

  Emergency Hospital Pirogov, Sofia, Bulgaria

  PRINCIPAL INVESTIGATOR

• Rossitza Vatcheva-Dobrevska, Prof

  University Hospital Queen Joanna, Sofia, Bulgaria

  PRINCIPAL INVESTIGATOR

• Sotirios Tsiodras, Prof

  Attikon University Hospital, Athens, Greece

  PRINCIPAL INVESTIGATOR

• Emmanuel Roilides, Prof

  Hippokration Hospital, Thessaloniki, Greece

  PRINCIPAL INVESTIGATOR

• Istvan Vakonyi, MD

  Kenezy University Hospital,Debrecen, Hungary

  PRINCIPAL INVESTIGATOR

• Aniko Farkas, MD

  Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház (SZSZBMK). Nyíregyháza, Hungary

  PRINCIPAL INVESTIGATOR

• Leonard Leibovici, Prof

  Beilinson Hospital, Rabin Medical Center. Petah-TiqvaI, Israel

  PRINCIPAL INVESTIGATOR

• Mical Paul, Prof

  Rambam Health Care Campus. Haifa, Israel

  PRINCIPAL INVESTIGATOR

• Yehuda Carmeli, Prof

  Tel Aviv Medical Center, Tel Aviv. Israel

  PRINCIPAL INVESTIGATOR

• Emanuele Durante Mangoni, Prof

  AORN dei Colli Monaldi. Napoli, Italy

  PRINCIPAL INVESTIGATOR

• Erica Franceschini, MD

  Azienda ospedaliero-universitaria policlinico di modena, Modena, Italy

  PRINCIPAL INVESTIGATOR

• Nicola Petrosillo, MD

  National Institute for Infectious Diseases L. Spallanzani, IRCCS, Rome, Italy

  PRINCIPAL INVESTIGATOR

• Andrei Ursache, MD

  "Spitalul Clinic de Urgenta Bucuresti. Popular unoficial name ""Floreasca "" Hospital", Bucharest, Romania

  PRINCIPAL INVESTIGATOR

• Judit Bodnár, MD

  Soproni Erzsébet Oktató Kórház és Rehabilitációs Intézet, Sopron, Hungary

  PRINCIPAL INVESTIGATOR

• Yehuda Carmeli, Prof

  Tel Aviv Medical Center, Tel Aviv, Israel

  PRINCIPAL INVESTIGATOR

• Andrei Vata, MD

  Infectious Diseases Hospital Sfanta Parascheva Iasi, Iasi, Romania

  PRINCIPAL INVESTIGATOR

• Adriana Hristea, MD

  National Institute for Infectious Diseases Prof Dr Matei Bals, Bucharest, Romania

  PRINCIPAL INVESTIGATOR

• Jesus Rodriguez-Bano, Prof

  Hospital Universitario Virgen Macarena, Seville, Spain

  PRINCIPAL INVESTIGATOR

• Julia Origüen, MD

  Hospital Universitario 12 de Octubre, Madrid, Spain

  PRINCIPAL INVESTIGATOR

• Arzu Yetkin, MD

  Ankara Numune Egitim ve ArastÄrma Hastanesi, Ankara, Turkey

  PRINCIPAL INVESTIGATOR

• Nese Saltoglu, Prof

  Istanbul University Cerrahpasa Medical School, Istambul, Turkey

  PRINCIPAL INVESTIGATOR

• Miquel Pujol, MD

  Hospital Universitari de Bellvitge, Barcelona, Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: December 23, 2015
• First Posted: December 29, 2015
• Study Start: December 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: January 18, 2017

Record last verified: 2017-01

Locations

GR (2); IL (3); RO (3); ES (3); HU (3); BU (2); IT (3); TU (2)