Status:
COMPLETED
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
Lead Sponsor:
Erasme University Hospital
Collaborating Sponsors:
University Hospital, Lille
Universitair Ziekenhuis Brussel
Conditions:
Asymptomatic Bacteriuria
Bacteriuria
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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
- Kidney transplant recipient with asymptomatic bacteriuria after the first two months post-transplantation
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2019
Estimated Enrollment :
198 Patients enrolled
Trial Details
Trial ID
NCT01871753
Start Date
April 1 2014
End Date
July 1 2019
Last Update
July 18 2019
Active Locations (15)
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1
Universitair Ziekenhuis Antwerpen
Antwerp, Belgium, 2650
2
Centre Hospitalier Epicura
Baudour, Belgium, 7331
3
Centre Hospitalier Universitaire Brugmann
Brussels, Belgium, 1020
4
Hôpital Universitaire Erasme
Brussels, Belgium, 1070