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Urinary Tract InfectionsRESCUINGNCT02641015

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

An observational study of Urinary Tract Infections and Bacterial Resistance, run by Institut d'Investigació Biomèdica de Bellvitge at 21 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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) Read more about this study

Who is it for?
Ages 18 years and older
How many people
1,028 participants
Where
21 sitesin 8 countries
Study dates
Dec 2015to Aug 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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
Show all 18Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

21 sites in 8 countries.

21 sites in 8 countries

Hungary3 sites

  • Kenezy University Hospital

    Debrecen

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

    Nyíregyháza

  • Soproni Erzsébet Oktató Kórház és Rehabilitációs Intézet

    Sopron

Other trials in Hungary

Israel3 sites

  • Rambam Health Care Campus

    Haifa

  • Beilinson Hospital, Rabin Medical Center

    Petah Tikva

  • Tel Aviv Medical Center

    Tel Aviv

Other trials in Israel

Italy3 sites

  • Azienda Ospedaliero-Universitaria Policlinico Di Modena

    Modena

  • AORN dei Colli Monaldi

    Naples

  • National Institute for Infectious Diseases L. Spallanzani, IRCCS

    Rome

Other trials in Italy

Romania3 sites

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

    Bucharest

  • National Institute for Infectious Diseases Prof Dr Matei Bals

    Bucharest

  • Infectious Diseases Hospital Sfanta Parascheva Iasi

    Iași

Other trials in Romania

Spain3 sites

  • Hospital Universitari de Bellvitge

    L'Hospitalet Del Llobregat, Barcelona, 08907

  • Hospital Universitario 12 de Octubre

    Madrid

  • Hospital Universitario Virgen Macarena

    Seville

Other trials in Spain

Bulgaria2 sites

  • Emergency Hospital Pirogov

    Sofia

  • University Hospital Queen Joanna

    Sofia

Other trials in Bulgaria

Greece2 sites

  • Attikon University Hospital

    Athens

  • Hippokration Hospital

    Thessaloniki

Other trials in Greece

Turkey (Türkiye)2 sites

  • Ankara Numune Egitim ve Arastırma Hastanesi

    Ankara

  • Istanbul University Cerrahpasa Medical School

    Istanbul

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

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)

Read the detailed description

Bacterial resistance to antimicrobial drugs is a major public health problem. Of greatest concern is the rapid emergence and dissemination of resistance to third generation cephalosporins in Enterobacteriaceae, especially Escherichia coli and Klebsiella pneumoniae. This is frequently seen in association with resistance to other classes of antibiotics leading to a multidrug resistance (MDR) profile. These MDR isolates are often involved in complicated urinary tract infection (cUTI), and are associated with poor clinical outcomes. In addition, in the last decade there has been an emergence of carbapenemase-producing Enterobacteriaceae, which are also resistant to other antibiotics than carbapenems, leaving few therapeutic options.

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.

Keywords
UTI
Medical subject headings
Urinary Tract Infections

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 30 days

Secondary outcomes (11)

  1. Time to clinical response

    Time to clinical response (in days), since initiation of antibiotic treatment

    Measured: 30 days

  2. Time to urological intervention for source control

    Time to urological intervention for source control (in days) since initial cUTI diagnosis

    Measured: 30 days

  3. Time to death

    Time to death (in days) since original cUTI diagnosis

    Measured: 30 days

  4. Duration of antibiotic therapy

    Duration of antibiotic therapy (in days)

    Measured: 30 days

  5. Length of hospital stay

    Length of hospital stay (in days)

    Measured: 30 days

  6. Hospital mortality

    Hospital mortality during admission

    Measured: 30 days

  7. All cause mortality within 30 days of the original cUTI diagnosis

    All cause mortality within 30 days of the original cUTI diagnosis

    Measured: 30 days

  8. All cause of mortality for two months after hospital discharge

    All cause of mortality for two months after hospital discharge

    Measured: 60 days

  9. Cost per case of cUTI

    Cost per case of cUTI

    Measured: 30 days

  10. Readmissions to the hospital within 60 days of hospital discharge

    Readmissions to the hospital within 60 days of hospital discharge

    Measured: 60 days

  11. Adverse events related to antibiotic treatment including: moderate or severe allergic reactions, severe renal impairment, Clostridium difficile infection

    Adverse events related to antibiotic treatment including: moderate or severe allergic reactions, severe renal impairment, Clostridium difficile infection

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Dec 2015 (estimated)
  2. Study startDec 2015
  3. Primary completionAug 2016
  4. Study completionAug 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
1,028 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02641015
Sponsor's protocol ID
PR 223/15
Acronym
RESCUING
Status last verified
Jan 2017
First submitted
23 Dec 2015
Last updated
18 Jan 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 24287460

  • 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.

    PubMed 22763019

  • 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.

    PubMed 21291846

  • 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.

    PubMed 24071027

  • 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.

    PubMed 24573013

  • 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.

    PubMed 19696123

  • 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.

    PubMed 24158412

  • 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.

    PubMed 23378123

  • 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.

    PubMed 9098661

  • 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.

    PubMed 12113866

  • 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.

    PubMed 3558716

  • 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.

    PubMed 15509405

  • 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.

    PubMed 21793988

  • 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.

    PubMed 27473949

Questions about this trial

What is this clinical trial studying?

An observational study of Urinary Tract Infections and Bacterial Resistance, run by Institut d'Investigació Biomèdica de Bellvitge at 21 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in Hungary, Israel, Italy, Romania, Spain and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment Failure (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02641015, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2017.

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