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

Free University of Brussels (ULB)

Status and phase: Completed; Phase 4

Conditions: Asymptomatic Bacteriuria; Urinary Tract Infections; Kidney Transplantation; Bacteriuria

Treatments: Other: Anti-Infective Agents

Study type: Interventional

Funder types: Other

Identifiers

NCT01871753

BiRT study

2012-003857-26 (EudraCT Number)

Details and patient eligibility

About

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

Full description

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

Enrollment: 198 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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198 participants in 2 patient groups

Antibiotics

Experimental group

Description:

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).

Treatment:

Other: Anti-Infective Agents

No treatment

No Intervention group

Description:

no antibiotics delivered in case of asymptomatic bacteriuria, independently of the number of asymptomatic episodes.