Clinical trial NCT02641015: Study to Assess Management and Outcomes of Hospitalised Patients With Complicated UTI (RESCUING)
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Tract Infections
Bacterial Resistance
Keywords: UTI
Lead sponsor: Institut d'Investigació Biomèdica de Bellvitge
Sponsor class: OTHER
Collaborators: name: Tel Aviv University
name: AiCuris Anti-infective Cures AG
name: University of Bristol
name: UMC Utrecht
First posted: 2015-12-29
Enrollment: 1028
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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)

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.

Eligibility criteria: 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

Primary outcomes:
measure: Treatment Failure
timeFrame: 30 days
Secondary outcomes:
measure: Time to clinical response
timeFrame: 30 days
measure: Time to urological intervention for source control
timeFrame: 30 days
measure: Time to death
timeFrame: 30 days
measure: Duration of antibiotic therapy
timeFrame: 30 days
measure: Length of hospital stay
timeFrame: 30 days
measure: Hospital mortality
timeFrame: 30 days
measure: All cause mortality within 30 days of the original cUTI diagnosis
timeFrame: 30 days
measure: All cause of mortality for two months after hospital discharge
timeFrame: 60 days
measure: Cost per case of cUTI
timeFrame: 30 days
measure: Readmissions to the hospital within 60 days of hospital discharge
timeFrame: 60 days
measure: Adverse events related to antibiotic treatment including: moderate or severe allergic reactions, severe renal impairment, Clostridium difficile infection
timeFrame: 30 days
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
facility: Emergency Hospital Pirogov
city: Sofia
country: Bulgaria
facility: University Hospital Queen Joanna
city: Athens
country: Greece
facility: Attikon University Hospital
city: Thessaloniki
country: Greece
facility: Hippokration Hospital
city: Debrecen
country: Hungary
facility: Kenezy University Hospital
city: Nyíregyháza
country: Hungary
facility: Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház (SZSZBMK)
city: Sopron
country: Hungary
facility: Soproni Erzsébet Oktató Kórház és Rehabilitációs Intézet
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Petah-Tiqva
country: Israel
facility: Beilinson Hospital, Rabin Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Medical Center
city: Modena
country: Italy
facility: Azienda Ospedaliero-Universitaria Policlinico Di Modena
city: Napoli
country: Italy
facility: AORN dei Colli Monaldi
city: Rome
country: Italy
facility: National Institute for Infectious Diseases L. Spallanzani, IRCCS
city: Bucharest
country: Romania
facility: Spitalul Clinic de Urgenta Bucuresti. Popular unoficial name "Floreasca " Hospital
city: Bucharest
country: Romania
facility: National Institute for Infectious Diseases Prof Dr Matei Bals
city: Iasi
country: Romania
facility: Infectious Diseases Hospital Sfanta Parascheva Iasi
city: L'Hospitalet del Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
state: Barcelona
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Ankara
country: Turkey
facility: Ankara Numune Egitim ve ArastÄ±rma Hastanesi
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa Medical School
Study officials:
affiliation: Emergency Hospital Pirogov, Sofia, Bulgaria
name: Dora Tancheva, Mrs
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Queen Joanna, Sofia, Bulgaria
name: Rossitza Vatcheva-Dobrevska, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Attikon University Hospital, Athens, Greece
name: Sotirios Tsiodras, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Hippokration Hospital, Thessaloniki, Greece
name: Emmanuel Roilides, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Kenezy University Hospital,Debrecen, Hungary
name: Istvan Vakonyi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház (SZSZBMK). Nyíregyháza, Hungary
name: Aniko Farkas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beilinson Hospital, Rabin Medical Center. Petah-TiqvaI, Israel
name: Leonard Leibovici, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Rambam Health Care Campus. Haifa, Israel
name: Mical Paul, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Tel Aviv Medical Center, Tel Aviv. Israel
name: Yehuda Carmeli, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: AORN dei Colli Monaldi. Napoli, Italy
name: Emanuele Durante Mangoni, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Azienda ospedaliero-universitaria policlinico di modena, Modena, Italy
name: Erica Franceschini, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Institute for Infectious Diseases L. Spallanzani, IRCCS, Rome, Italy
name: Nicola Petrosillo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: "Spitalul Clinic de Urgenta Bucuresti. Popular unoficial name ""Floreasca "" Hospital", Bucharest, Romania
name: Andrei Ursache, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Soproni Erzsébet Oktató Kórház és Rehabilitációs Intézet, Sopron, Hungary
name: Judit BodnÃ¡r, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tel Aviv Medical Center, Tel Aviv, Israel
name: Yehuda Carmeli, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Infectious Diseases Hospital Sfanta Parascheva Iasi, Iasi, Romania
name: Andrei Vata, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Institute for Infectious Diseases Prof Dr Matei Bals, Bucharest, Romania
name: Adriana Hristea, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Virgen Macarena, Seville, Spain
name: Jesus Rodriguez-Bano, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario 12 de Octubre, Madrid, Spain
name: Julia Origüen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ankara Numune Egitim ve ArastÄrma Hastanesi, Ankara, Turkey
name: Arzu Yetkin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul University Cerrahpasa Medical School, Istambul, Turkey
name: Nese Saltoglu, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitari de Bellvitge, Barcelona, Spain
name: Miquel Pujol, MD
role: PRINCIPAL_INVESTIGATOR
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