Clinical trial NCT01871753: 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
Official title: 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: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asymptomatic Bacteriuria
Bacteriuria
Urinary Tract Infections
Kidney Transplantation
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
Collaborators: name: University Hospital, Lille
name: Universitair Ziekenhuis Brussel
name: Hôpital Necker Enfants-Malades, Université de Paris Descartes, APHP, France
name: Centre Hospitalier Universitaire Brugmann
name: Centre Hospitalier Universitaire de Charleroi
name: University Ghent
name: Centre Hospitalier Epicura, Belgium
name: University of Liege
name: Nantes University Hospital
First posted: 2013-06-07
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: cumulative incidence of a first episode of symptomatic urinary tract infection
timeFrame: 12 months
Secondary outcomes:
measure: incidence of a first episode of pyelonephritis
timeFrame: 12 months
measure: clearance of asymptomatic bacteriuria
timeFrame: 12 months
measure: occurrence of new episodes of asymptomatic bacteriuria
timeFrame: 12 months
measure: graft function/graft survival
timeFrame: 12 months
measure: incidence of graft rejection
timeFrame: 12 months
measure: patient survival
timeFrame: 12 months
measure: utility of a control urine culture for diagnosis of asymptomatic bacteriuria in kidney transplant recipients
timeFrame: 12 months
measure: level of antimicrobial resistance in bacteria responsible for symptomatic urinary tract infections
timeFrame: 12 months
measure: total number of days of antimicrobial therapy
timeFrame: 12 months
measure: cost of antimicrobial treatment for asymptomatic bacteriuria and symptomatic urinary tract infection
timeFrame: 12 months
measure: number of hospitalizations for asymptomatic bacteriuria and symptomatic urinary tract infection treatment
timeFrame: 12 months
measure: total number of symptomatic urinary tract infections in both groups
timeFrame: 12 months
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
city: Baudour
country: Belgium
facility: Centre Hospitalier Epicura
city: Brussels
country: Belgium
facility: Centre Hospitalier Universitaire Brugmann
city: Brussels
country: Belgium
facility: Hôpital Universitaire Erasme
city: Brussels
country: Belgium
facility: Universitair Ziekenhuis Brussel - Vrije Universiteit Brussel
city: Charleroi
country: Belgium
facility: Centre Hospitalier Universitaire de Charleroi
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Liège
country: Belgium
facility: Centre Hospitalier Universitaire de Liège
city: Créteil
country: France
facility: Groupe Henri Mondor-Albert Chenevier, Assistance Publique-Hôpitaux de Paris
city: Lille
country: France
facility: Centre Hospitalier Régional Universitaire de Lille
city: Nantes
country: France
facility: Centre Hospitalier Universitaire de Nantes
city: Paris
country: France
facility: Department of Kidney Transplantation, Hôpital Necker Enfants-Malades, Université de Paris Descartes, APHP
city: Paris
country: France
facility: Hôpital Tenon, Assistance Publique-Hôpitaux de Paris
city: Saint-Étienne
country: France
facility: Centre Hospitalier Universitaire de Saint-Étienne
city: Toulouse
country: France
facility: Centre Hospitalier Universitaire Rangueil
Study officials:
affiliation: Hôpital Universitaire Erasme, Brussels, Belgium
name: Julien Coussement, MD
role: STUDY_DIRECTOR
References: