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