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