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

Phase 4

Completed

• Conditions: Urinary Tract Infections; Bacteriuria; Asymptomatic Bacteriuria; Kidney Transplantation
• Interventions: Other: Anti-Infective Agents

• Registration Number: NCT01871753
• Lead Sponsor: Erasme University Hospital

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2013-05-31
• Study First Submitted QC: 2013-06-06
• Study First Posted: 2013-06-07
• Study Start: 2014-04
• Status Verified: 2019-07
• Primary Completion: 2019-07
• Study Completion: 2019-07
• Last Update Submitted: 2019-07-16
• Last Update Posted: 2019-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 198

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Antibiotics	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).

Primary Outcome Measures

Name	Time	Method
cumulative incidence of a first episode of symptomatic urinary tract infection	12 months

Secondary Outcome Measures

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

Trial Locations

Locations (15)

Centre Hospitalier Universitaire de Charleroi; 🇧🇪 Charleroi, Belgium

Centre Hospitalier Universitaire de Nantes; 🇫🇷 Nantes, France

Hôpital Tenon, Assistance Publique-Hôpitaux de Paris; 🇫🇷 Paris, France

Centre Hospitalier Epicura; 🇧🇪 Baudour, Belgium

Centre Hospitalier Universitaire Brugmann; 🇧🇪 Brussels, Belgium

Groupe Henri Mondor-Albert Chenevier, Assistance Publique-Hôpitaux de Paris; 🇫🇷 Créteil, France

Universitair Ziekenhuis Antwerpen; 🇧🇪 Antwerpen, Belgium

Universitair Ziekenhuis Brussel - Vrije Universiteit Brussel; 🇧🇪 Brussels, Belgium

Centre Hospitalier Régional Universitaire de Lille; 🇫🇷 Lille, France

Hôpital Universitaire Erasme; 🇧🇪 Brussels, Belgium

Universitair Ziekenhuis Gent; 🇧🇪 Gent, Belgium

Centre Hospitalier Universitaire de Saint-Étienne; 🇫🇷 Saint-Étienne, France

Department of Kidney Transplantation, Hôpital Necker Enfants-Malades, Université de Paris Descartes, APHP; 🇫🇷 Paris, France

Centre Hospitalier Universitaire Rangueil; 🇫🇷 Toulouse, France

Centre Hospitalier Universitaire de Liège; 🇧🇪 Liège, Belgium