title: 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).
abstract: The emergence of multidrug resistant (MDR) Gram-negative bacteria (GNB), including carbapenemase-producing strains, has become a major therapeutic challenge. These MDR isolates are often involved in complicated urinary tract infection (cUTI), and are associated with poor clinical outcomes. The study has been designed to gain insight into the epidemiology, clinical management, outcome and healthcare cost of patients with cUTI, especially in countries with high prevalence of MDR GNB.
  
  
  
  This multinational and multicentre observational, retrospective study will identify cases from 1 January 2013 to 31 December 2014 in order to collect data on patients with cUTI as a cause of hospital admission, and patients who develop cUTI during their hospital stay. The primary end point will be treatment failure defined as the presence of any of the following criteria: (1) signs or symptoms of cUTI present at diagnosis that have not improved by days 5-7 with appropriate antibiotic therapy, (2) new cUTI-related symptoms that have developed within 30 days of diagnosis, (3) urine culture taken within 30 days of diagnosis, either during or after completion of therapy, that grows ≥10(4) colony-forming unit/mL of the original pathogen and (4) death irrespective of cause within 30 days of the cUTI diagnosis.
  
  
  
  1000 patients afford a power of 0.83 (α=0.05) to detect an absolute difference of 10% in the treatment failure rate between MDR bacteria and other pathogens. This should allow for the introduction of about 20 independent risk factors (or their interaction) in a logistic regression model looking at risk factors for failure.
  
  
  
  Approval will be sought from all relevant Research Ethics Committees. Publication of this study will be considered as a joint publication by the participating investigator leads, and will follow the recommendations of the International Committee of Medical Journal Editors (ICMJE).
  
  
  
  NCT02641015; Pre-results.
authors.affiliation: Departament of Infectious Diseases, Institut Català de la Salut-Hospital Universitari de Bellvitge (ICS-HUB)-IDIBELL, Barcelona, Spain Spanish network for research in Infectious Diseases (REIPI RD12/0012), Instituto de Salud Carlos III, Madrid Spain.
authors.forename: Evelyn
authors.initials: E
authors.lastname: Shaw
authors.affiliation: AiCuris Anti-infective Cures GmbH, Wuppertal, Germany.
authors.forename: Ibironke
authors.initials: I
authors.lastname: Addy
authors.affiliation: Department of Medical Microbiology, Southmead Hospital, North Bristol NHS Trust, Bristol, UK.
authors.forename: Margaret
authors.initials: M
authors.lastname: Stoddart
authors.affiliation: AiCuris Anti-infective Cures GmbH, Wuppertal, Germany.
authors.forename: Christiane
authors.initials: C
authors.lastname: Vank
authors.affiliation: Department of Medical Microbiology, Southmead Hospital, North Bristol NHS Trust, Bristol, UK.
authors.forename: Sally
authors.initials: S
authors.lastname: Grier
authors.affiliation: AiCuris Anti-infective Cures GmbH, Wuppertal, Germany.
authors.forename: Irith
authors.initials: I
authors.lastname: Wiegand
authors.affiliation: Department of Medicine E, Beilinson Hospital, Rabin Medical Center, Petah-Tiqva, Israel Sackler Faculty of Medicine, Tel-Aviv University, Petah Tikva, Israel.
authors.forename: Leonard
authors.initials: L
authors.lastname: Leibovici
authors.affiliation: Department of Medicine E, Beilinson Hospital, Rabin Medical Center, Petah-Tiqva, Israel Sackler Faculty of Medicine, Tel-Aviv University, Petah Tikva, Israel.
authors.forename: Noa
authors.initials: N
authors.lastname: Eliakim-Raz
authors.affiliation: Department of Applied Health Research, University College London, London, UK.
authors.forename: Laura
authors.initials: L
authors.lastname: Vallejo-Torres
authors.affiliation: Department of Applied Health Research, University College London, London, UK.
authors.forename: Stephen
authors.initials: S
authors.lastname: Morris
authors.affiliation: Department of Medical Microbiology, Southmead Hospital, North Bristol NHS Trust, Bristol, UK.
authors.forename: Alasdair
authors.initials: A
authors.lastname: MacGowan
authors.affiliation: Departament of Infectious Diseases, Institut Català de la Salut-Hospital Universitari de Bellvitge (ICS-HUB)-IDIBELL, Barcelona, Spain Spanish network for research in Infectious Diseases (REIPI RD12/0012), Instituto de Salud Carlos III, Madrid Spain.
authors.forename: Jordi
authors.initials: J
authors.lastname: Carratalà
authors.affiliation: Departament of Infectious Diseases, Institut Català de la Salut-Hospital Universitari de Bellvitge (ICS-HUB)-IDIBELL, Barcelona, Spain Spanish network for research in Infectious Diseases (REIPI RD12/0012), Instituto de Salud Carlos III, Madrid Spain.
authors.forename: Miquel
authors.initials: M
authors.lastname: Pujol
mesh_terms: D000368:Aged; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D002985:Clinical Protocols; D024901:Drug Resistance, Multiple, Bacterial / Q000187:drug effects*; D005260:Female; D006090:Gram-Negative Bacteria / Q000187:drug effects*; D016905:Gram-Negative Bacterial Infections / Q000188:drug therapy* / Q000453:epidemiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D015995:Prevalence; D012189:Retrospective Studies; D012307:Risk Factors; D014552:Urinary Tract Infections / Q000188:drug therapy* / Q000453:epidemiology
chemical_list: D000900:Anti-Bacterial Agents
keywords: Catheter related urinary tract infections; Complicated urinary tract infections; Cost assessments; Outcomes; Risk factors