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

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

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

Official Title
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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

Conditions
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Asymptomatic Bacteriuria, Bacteriuria, Urinary Tract Infections, Kidney Transplantation

Intervention / Treatment
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* Other: Anti-Infective Agents


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Antibiotics<br>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<br>* 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)<br>* Other names: The choice of antimicrobial agent is at the discretion of the physician, and is based on the antibiogram results;|
| No Intervention: No treatment<br>no antibiotics delivered in case of asymptomatic bacteriuria, independently of the number of asymptomatic episodes. | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |