Should we treat asymptomatic bacteriuria in kidney transplant recipients? A prospective, randomized, multicenter trial.

• Conditions: Asymptomatic bacteriuria after renal transplantation.; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2012-003857-26-BE
• Lead Sponsor: B ERASME HOSPITA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12-07
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

asymptomatic bacteriuria in kidney transplant recipients after first two months post transplantation
asymptomatic bacteriuria is define as isolation of a single bacterial species in a quantitative count>= 100.000 CFU/ml in a single collected urine specimen from a patient without biological or clinical signs or symptoms referable to urinary tract infection.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 130
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 130

Exclusion Criteria

1. Pregnant women or women who wish to become pregnant during the course of the study
2. Presence of indwelling urinary devices such as urethral catheter, ureteral catheter, nephrostomy and/or suprapubic catheter
3. Combined transplantation (liver-kidney, lung-kidney, heart-kidney)
4. Urinary tract surgery during the last two months
5. Surgical urological procedure planned in the next two weeks
6. Neutropenia (<= 500/mm3)
7. 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
8. Use of antibiotics at the time of asymptomatic bacteriuria (except for prevention of pneumocystis jiroveci)
9. End Stage Renal Disease requiring dialysis
10. Non-functionning native bladder (e.g. bladder dysfunction requiring intermittent self-catheterization, orthotopic ileal bladder)
11. Recurrent pyelonephritis (>= 2 episodes in the last year)
12. kidney transplant recipients who could not return for regular follow-up

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified