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 (BiRT)

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.

Study Overview

• Status: Completed
• Conditions: Bacteriuria; Urinary Tract Infections; Kidney Transplantation; Asymptomatic Bacteriuria
• Intervention / Treatment: Other: Anti-Infective Agents

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 198
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Antwerpen, Belgium, 2650
    • Universitair Ziekenhuis Antwerpen
  • Baudour, Belgium, 7331
    • Centre Hospitalier EpiCURA
  • Brussels, Belgium, 1070
    • Hopital Universitaire Erasme
  • Brussels, Belgium, 1020
    • Centre Hospitalier Universitaire Brugmann
  • Brussels, Belgium, 1090
    • Universitair Ziekenhuis Brussel - Vrije Universiteit Brussel
  • Charleroi, Belgium, 6110
    • Centre Hospitalier Universitaire de Charleroi
  • Gent, Belgium, 9000
    • Universitair Ziekenhuis Gent
  • Liège, Belgium, 4000
    • Centre Hospitalier Universitaire de Liege
• France
  • Créteil, France, 94000
    • Groupe Henri Mondor-Albert Chenevier, Assistance Publique-Hôpitaux de Paris
  • Lille, France, 59037
    • Centre Hospitalier Regional Universitaire de Lille
  • Nantes, France, 44000
    • Centre Hospitalier Universitaire de Nantes
  • Paris, France, 75015
    • Department of Kidney Transplantation, Hôpital Necker Enfants-Malades, Université de Paris Descartes, APHP
  • Paris, France, 75020
    • Hôpital Tenon, Assistance Publique-Hôpitaux de Paris
  • Saint-Étienne, France, 42055
    • Centre Hospitalier Universitaire de Saint-Étienne
  • Toulouse, France, 31059
    • Centre Hospitalier Universitaire Rangueil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).	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); Other Names: Anti-Infective Agents: not applicable - no specific agent; The choice of antimicrobial agent is at the discretion of the physician, and is based on the antibiogram results
No Intervention: No treatment; no antibiotics delivered in case of asymptomatic bacteriuria, independently of the number of asymptomatic episodes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
cumulative incidence of a first episode of symptomatic urinary tract infection	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
incidence of a first episode of pyelonephritis	12 months
clearance of asymptomatic bacteriuria	12 months
occurrence of new episodes of asymptomatic bacteriuria	12 months
graft function/graft survival	12 months
incidence of graft rejection	12 months
patient survival	12 months
utility of a control urine culture for diagnosis of asymptomatic bacteriuria in kidney transplant recipients	12 months
level of antimicrobial resistance in bacteria responsible for symptomatic urinary tract infections	12 months
total number of days of antimicrobial therapy	12 months
cost of antimicrobial treatment for asymptomatic bacteriuria and symptomatic urinary tract infection	12 months
number of hospitalizations for asymptomatic bacteriuria and symptomatic urinary tract infection treatment	12 months
total number of symptomatic urinary tract infections in both groups	12 months

Collaborators and Investigators

• Sponsor: Erasme University Hospital
• Collaborators: University of Liege; Universitair Ziekenhuis Brussel; University Hospital, Lille; Nantes University Hospital; University Ghent; Centre Hospitalier Universitaire de Charleroi; Centre Hospitalier Universitaire Brugmann; Hôpital Necker Enfants-Malades, Université de Paris Descartes, APHP, France; Centre Hospitalier Epicura, Belgium
• Investigators: Study Director: Julien Coussement, MD, Hôpital Universitaire Erasme, Brussels, Belgium

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2014
• Primary Completion (Actual): July 1, 2019
• Study Completion (Actual): July 1, 2019

Study Registration Dates

• First Submitted: May 31, 2013
• First Submitted That Met QC Criteria: June 6, 2013
• First Posted (Estimate): June 7, 2013

Study Record Updates

• Last Update Posted (Actual): July 18, 2019
• Last Update Submitted That Met QC Criteria: July 16, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Infections; Communicable Diseases; Urinary Tract Infections; Bacteriuria; Anti-Infective Agents
• Other Study ID Numbers: BiRT study; 2012-003857-26 (EudraCT Number)