Clinical Trial on Urinary Tract Infections, Bacterial Resistance - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

1028

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Bulgaria
- - Sofia, Bulgaria
    - Emergency Hospital Pirogov
  - Sofia, Bulgaria
    - University Hospital Queen Joanna
Greece
- - Athens, Greece
    - Attikon University Hospital
  - Thessaloniki, Greece
    - Hippokration Hospital
Hungary
- - Debrecen, Hungary
    - Kenezy University Hospital
  - Nyíregyháza, Hungary
    - Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház (SZSZBMK)
  - Sopron, Hungary
    - Soproni Erzsebet Oktato Korhaz es Rehabilitacios Intezet
Israel
- - Haifa, Israel
    - Rambam Health Care Campus
  - Petah-Tiqva, Israel
    - Beilinson Hospital, Rabin medical Center
  - Tel Aviv, Israel
    - Tel Aviv Medical Center
Italy
- - Modena, Italy
    - Azienda Ospedaliero-Universitaria Policlinico di Modena
  - Napoli, Italy
    - AORN dei Colli Monaldi
  - Rome, Italy
    - National Institute for Infectious Diseases L. Spallanzani, IRCCS
Romania
- - Bucharest, Romania
    - "Spitalul Clinic de Urgenta Bucuresti. Popular unoficial name ""Floreasca "" Hospital"
  - Bucharest, Romania
    - National Institute for Infectious Diseases Prof Dr Matei Bals
  - Iasi, Romania
    - Infectious Diseases Hospital Sfanta Parascheva Iasi
Spain
- - Madrid, Spain
    - Hospital Universitario 12 de Octubre
  - Sevilla, Spain
    - Hospital Universitario Virgen Macarena
- Barcelona
  - L'Hospitalet del Llobregat, Barcelona, Spain, 08907
    - Hospital Universitari de Bellvitge
Turkey
- - Ankara, Turkey
    - Ankara Numune Egitim ve ArastÄ±rma Hastanesi
  - Istanbul, Turkey
    - Istanbul University Cerrahpasa Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

Inclusion Criteria:

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

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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Failure Time Frame: 30 days	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to clinical response Time Frame: 30 days	Time to clinical response (in days), since initiation of antibiotic treatment	30 days
Time to urological intervention for source control Time Frame: 30 days	Time to urological intervention for source control (in days) since initial cUTI diagnosis	30 days
Time to death Time Frame: 30 days	Time to death (in days) since original cUTI diagnosis	30 days
Duration of antibiotic therapy Time Frame: 30 days	Duration of antibiotic therapy (in days)	30 days
Length of hospital stay Time Frame: 30 days	Length of hospital stay (in days)	30 days
Hospital mortality Time Frame: 30 days	Hospital mortality during admission	30 days
All cause mortality within 30 days of the original cUTI diagnosis Time Frame: 30 days	All cause mortality within 30 days of the original cUTI diagnosis	30 days
All cause of mortality for two months after hospital discharge Time Frame: 60 days	All cause of mortality for two months after hospital discharge	60 days
Cost per case of cUTI Time Frame: 30 days	Cost per case of cUTI	30 days
Readmissions to the hospital within 60 days of hospital discharge Time Frame: 60 days	Readmissions to the hospital within 60 days of hospital discharge	60 days
Adverse events related to antibiotic treatment including: moderate or severe allergic reactions, severe renal impairment, Clostridium difficile infection Time Frame: 30 days	Adverse events related to antibiotic treatment including: moderate or severe allergic reactions, severe renal impairment, Clostridium difficile infection	30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut d'Investigació Biomèdica de Bellvitge

Collaborators

UMC Utrecht

Tel Aviv University

University of Bristol

AiCuris Anti-infective Cures AG

Investigators

Principal Investigator: Sotirios Tsiodras, Prof, Attikon University Hospital, Athens, Greece
Principal Investigator: Dora Tancheva, Mrs, Emergency Hospital Pirogov, Sofia, Bulgaria
Principal Investigator: Rossitza Vatcheva-Dobrevska, Prof, University Hospital Queen Joanna, Sofia, Bulgaria
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 BodnÃ¡r, 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

December 23, 2015

First Submitted That Met QC Criteria