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

The Bacteriuria in Renal Transplantation (BiRT) Study: A Prospective, Randomized, Parallel-group, Multicenter, Open-label, Superiority Trial Comparing Antibiotics Versus no Treatment in the Prevention of Symptomatic Urinary Tract Infection in Kidney Transplant Recipients With Asymptomatic Bacteriuria

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

The BiRT trial investigators would be interested to collaborate with some additional hospitals, particularly centers having high level of antimicrobial resistance.

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