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Register:	ClinicalTrials.gov
Last refreshed on:	16 December 2017
Main ID:	NCT02641015
Date of registration:	23/12/2015
Prospective Registration:	No
Primary sponsor:	Institut d'Investigació Biomèdica de Bellvitge
Public title:	Study to Assess Management and Outcomes of Hospitalised Patients With Complicated UTI (RESCUING) RESCUING
Scientific 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.
Date of first enrolment:	December 2015
Target sample size:	1028
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02641015
Study type:	Observational
Study design:
Phase:	N/A

Countries of recruitment
Bulgaria	Greece	Hungary	Israel	Italy	Romania	Spain	Turkey

Contacts

Name:	Judit BodnÃ¡r, MD
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Affiliation:	Soproni Erzsébet Oktató Kórház és Rehabilitációs Intézet, Sopron, Hungary

Name:	Yehuda Carmeli, Prof
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Affiliation:	Tel Aviv Medical Center, Tel Aviv. Israel

Name:	Emanuele Durante Mangoni, Prof
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Affiliation:	AORN dei Colli Monaldi. Napoli, Italy

Name:	Leonard Leibovici, Prof
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Affiliation:	Beilinson Hospital, Rabin Medical Center. Petah-TiqvaI, Israel

Name:	Adriana Hristea, MD
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Affiliation:	National Institute for Infectious Diseases Prof Dr Matei Bals, Bucharest, Romania

Name:	Rossitza Vatcheva-Dobrevska, Prof
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Affiliation:	University Hospital Queen Joanna, Sofia, Bulgaria

Name:	Andrei Ursache, MD
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Affiliation:	"Spitalul Clinic de Urgenta Bucuresti. Popular unoficial name ""Floreasca "" Hospital", Bucharest, Romania

Name:	Dora Tancheva, Mrs
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Affiliation:	Emergency Hospital Pirogov, Sofia, Bulgaria

Name:	Miquel Pujol, MD
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Affiliation:	Hospital Universitari de Bellvitge, Barcelona, Spain

Name:	Jesus Rodriguez-Bano, Prof
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Affiliation:	Hospital Universitario Virgen Macarena, Seville, Spain

Name:	Nese Saltoglu, Prof
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Affiliation:	Istanbul University Cerrahpasa Medical School, Istambul, Turkey

Name:	Yehuda Carmeli, Prof
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Affiliation:	Tel Aviv Medical Center, Tel Aviv, Israel

Name:	Arzu Yetkin, MD
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Affiliation:	Ankara Numune Egitim ve ArastÄrma Hastanesi, Ankara, Turkey

Name:	Nicola Petrosillo, MD
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Affiliation:	National Institute for Infectious Diseases L. Spallanzani, IRCCS, Rome, Italy

Name:	Aniko Farkas, MD
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Affiliation:	Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház (SZSZBMK). Nyíregyháza, Hungary

Name:	Andrei Vata, MD
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Affiliation:	Infectious Diseases Hospital Sfanta Parascheva Iasi, Iasi, Romania

Name:	Istvan Vakonyi, MD
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Affiliation:	Kenezy University Hospital,Debrecen, Hungary

Name:	Mical Paul, Prof
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Affiliation:	Rambam Health Care Campus. Haifa, Israel

Name:	Erica Franceschini, MD
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Affiliation:	Azienda ospedaliero-universitaria policlinico di modena, Modena, Italy

Name:	Julia Origüen, MD
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Affiliation:	Hospital Universitario 12 de Octubre, Madrid, Spain

Name:	Sotirios Tsiodras, Prof
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Affiliation:	Attikon University Hospital, Athens, Greece

Name:	Emmanuel Roilides, Prof
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Affiliation:	Hippokration Hospital, Thessaloniki, Greece

Key inclusion & exclusion 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

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Bacterial Resistance

Urinary Tract Infections

Intervention(s)

Primary Outcome(s)

Treatment Failure [Time Frame: 30 days]

Secondary Outcome(s)

All cause mortality within 30 days of the original cUTI diagnosis [Time Frame: 30 days]

Time to clinical response [Time Frame: 30 days]

Time to death [Time Frame: 30 days]

Time to urological intervention for source control [Time Frame: 30 days]

Length of hospital stay [Time Frame: 30 days]

All cause of mortality for two months after hospital discharge [Time Frame: 60 days]

Duration of antibiotic therapy [Time Frame: 30 days]

Hospital mortality [Time Frame: 30 days]

Adverse events related to antibiotic treatment including: moderate or severe allergic reactions, severe renal impairment, Clostridium difficile infection [Time Frame: 30 days]

Cost per case of cUTI [Time Frame: 30 days]

Readmissions to the hospital within 60 days of hospital discharge [Time Frame: 60 days]

Secondary ID(s)

PR 223/15

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

AiCuris Anti-infective Cures GmbH

UMC Utrecht

Tel Aviv University

University of Bristol

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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