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

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2019

Detailed Description

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

Interventions

  • Other: Anti-Infective Agents
    • 10 days of antibiotics, started and selected according to the antibiogram results. In case of reinfection or relapse, re-administration of antimicrobial agents will be performed according to the antibiogram results (for a maximum of 3 cycles of ten days of antibiotics during the 12 months of the follow-up)

Arms, Groups and Cohorts

  • Experimental: Antibiotics
    • 10 days of antibiotics, started and selected according to the antibiogram results. In case of reinfection or relapse, re-administration of antimicrobial agents will be performed according to the antibiogram results (for a maximum of 3 cycles of ten days of antibiotics during the 12 months of the follow-up).
  • No Intervention: No treatment
    • no antibiotics delivered in case of asymptomatic bacteriuria, independently of the number of asymptomatic episodes.

Clinical Trial Outcome Measures

Primary Measures

  • cumulative incidence of a first episode of symptomatic urinary tract infection
    • Time Frame: 12 months

Secondary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Erasme University Hospital
  • Collaborator
    • University Hospital, Lille
  • Provider of Information About this Clinical Study
    • Principal Investigator: Julien Coussement, MD, Julien Coussement, MD – Erasme University Hospital
  • Overall Official(s)
    • Julien Coussement, MD, Study Director, Hôpital Universitaire Erasme, Brussels, Belgium

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