The Bacteriuria in Renal Transplantation (BiRT) Study: A Trial Comparing Antibiotics Versus no Tr… (NCT01871753) | Clinical Trial Compass
CompletedPhase 4
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
Belgium198 participantsStarted 2014-04
Plain-language summary
The purpose of this study is to compare antibiotics versus no-treatment in kidney transplant recipients with asymptomatic bacteriuria.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Kidney transplant recipient with asymptomatic bacteriuria after the first two months post-transplantation
Exclusion Criteria:
* Pregnant women or women who wish to become pregnant during the course of the study
* Presence of indwelling urinary devices such as urethral catheter, ureteral catheter, nephrostomy and/or suprapubic catheter
* Combined transplantation (liver-kidney, lung-kidney, heart-kidney)
* Urinary tract surgery during the last two months
* Surgical urological procedure planned in the next 2 weeks
* Neutropenia (≤ 500 neutrophils/mm3)
* Important intensification of immunosuppression (Solumedrol bolus and/or use of thymoglobulin) or any other treatment of an acute graft rejection in the last two months
* Use of antibiotics at the time of the asymptomatic bacteriuria (except for prevention of Pneumocystis jirovecii)
* End-Stage Renal Disease (ESRD) requiring dialysis
* Non-functioning native bladder (e.g. bladder dysfunction requiring intermittent self-catheterization, orthotopic ileal neobladder)
* Recurrent acute graft pyelonephritis (≥ 2 episodes in the last year)
* Kidney transplant recipients who could not return for regular follow-up
What they're measuring
1
cumulative incidence of a first episode of symptomatic urinary tract infection