Clinical Trial: The Bacteriuria in Renal Transplantation (BiRT) Study: A Trial Comparing Antibiotics Versus no Treatment in the Prevention of Symptomatic Urinary Tract Infection in Kidney Transplant Recipients With Asymptomatic Bacteriuria

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: The Bacteriuria in Renal Transplantation (BiRT) Study: A Prospective, Randomized, Parallel-group, Multicenter, Open-label, Superiority Trial Comparing Antibiotics Versus n

Brief Summary: The purpose of this study is to compare antibiotics versus no-treatment in kidney transplant recipients with asymptomatic bacteriuria.

Detailed Summary: The BiRT trial investigators would be interested to collaborate with some additional hospitals, particularly centers having high level of antimicrobial resistance.
Sponsor: Erasme University Hospital

Current Primary Outcome: cumulative incidence of a first episode of symptomatic urinary tract infection [ Time Frame: 12 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • incidence of a first episode of pyelonephritis [ Time Frame: 12 months ]
  • clearance of asymptomatic bacteriuria [ Time Frame: 12 months ]
  • occurrence of new episodes of asymptomatic bacteriuria [ Time Frame: 12 months ]
  • graft function/graft survival [ Time Frame: 12 months ]
  • incidence of graft rejection [ Time Frame: 12 months ]
  • patient survival [ Time Frame: 12 months ]
  • utility of a control urine culture for diagnosis of asymptomatic bacteriuria in kidney transplant recipients [ Time Frame: 12 months ]
  • level of antimicrobial resistance in bacteria responsible for symptomatic urinary tract infections [ Time Frame: 12 months ]
  • total number of days of antimicrobial therapy [ Time Frame: 12 months ]
  • cost of antimicrobial treatment for asymptomatic bacteriuria and symptomatic urinary tract infection [ Time Frame: 12 months ]
  • number of hospitalizations for asymptomatic bacteriuria and symptomatic urinary tract infection treatment [ Time Frame: 12 months ]
  • total number of symptomatic urinary tract infections in both groups [ Time Frame: 12 months ]


Original Secondary Outcome: Same as current

Information By: Erasme University Hospital

Dates:
Date Received: May 31, 2013
Date Started: January 2014
Date Completion:
Last Updated: August 3, 2016
Last Verified: August 2016