The Bacteriuria In Renal Transplantation study: A prospective, randomized, multicenter trial comparing antibiotics versus no treatment in the prevention of urinary tract infection in kidney transplant reicipients with asymptomatic bacteriuria. - BIRT

B ERASME HOSPITA0 个研究点目标入组 130 人开始时间: 2012年12月7日最近更新: 2014年10月7日

适应症

试验速览

暂无简介。

•asymptomatic bacteriuria in kidney transplant recipients after first two months post transplantation
•asymptomatic bacteriuria is define as isolation of a single bacterial species in a quantitative count>= 100.000 CFU/ml in a single collected urine specimen from a patient without biological or clinical signs or symptoms referable to urinary tract infection.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 130
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 130

•1. Pregnant women or women who wish to become pregnant during the course of the study
•2. Presence of indwelling urinary devices such as urethral catheter, ureteral catheter, nephrostomy and/or suprapubic catheter
•3. Combined transplantation (liver-kidney, lung-kidney, heart-kidney)
•4. Urinary tract surgery during the last two months
•5. Surgical urological procedure planned in the next two weeks
•6. Neutropenia (<= 500/mm3)
•7. 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
•8. Use of antibiotics at the time of asymptomatic bacteriuria (except for prevention of pneumocystis jiroveci)
•9. End Stage Renal Disease requiring dialysis
•10. Non-functionning native bladder (e.g. bladder dysfunction requiring intermittent self-catheterization, orthotopic ileal bladder)
•11. Recurrent pyelonephritis (>= 2 episodes in the last year)
•12. kidney transplant recipients who could not return for regular follow-up

发起方

B ERASME HOSPITA