Asymptomatic Bacteriuria, Bacteriuria, Kidney Transplantation, Urinary Tract Infections
Conditions
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.
Interventions
OTHERAnti-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)
Sponsors
University Hospital, Lille
Universitair Ziekenhuis Brussel
Hôpital Necker Enfants-Malades, Université de Paris Descartes, APHP, France
Centre Hospitalier Universitaire Brugmann
Centre Hospitalier Universitaire de Charleroi
University Ghent
Centre Hospitalier Epicura, Belgium
University of Liege
Nantes University Hospital
Erasme University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| cumulative incidence of a first episode of symptomatic urinary tract infection | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| incidence of a first episode of pyelonephritis | 12 months |
| clearance of asymptomatic bacteriuria | 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 |
| utility of a control urine culture for diagnosis of asymptomatic bacteriuria in kidney transplant recipients | 12 months |
Countries
Belgium, France
Outcome results
None listed