EUCTR2012-003857-26-BEActive, not recruitingNot Applicable
The Bacteriuria In Renal Transplantation study: A prospective, randomized, multicenter trial comparing antibiotics versus no treatment in the prevention of urinary tract infection in kidney transplant reicipients with asymptomatic bacteriuria. - BIRT
B ERASME HOSPITA0 sites130 target enrollmentStarted: December 7, 2012Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 130
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
Investigators
Similar Trials
Completed
Phase 4
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 BacteriuriaAsymptomatic BacteriuriaBacteriuriaUrinary Tract InfectionsKidney TransplantationNCT01871753Erasme University Hospital198
Active, not recruiting
Not Applicable
BK viremi efter njurtransplantation: Screening, tidig diagnostik, tidig reduktion av immunhämning samt behandling med leflunomid (Arava®) - BK ViremiaEUCTR2008-005727-28-SEKarolinska Universitetssjukhuset
Recruiting
Not Applicable
A clinical study of living-related renal transplantation with restored kidneys (interventional trial)iving renal transplantations between family members with restored donor kidneys in order to acquire necessary clinical data for potential enrichment of the renal donor pool in Japan as well as to develop useful medical care for patients who are on dialysis for many years due to the renal failure.JPRN-UMIN000003257Tokushukai Medical Group5
Unknown
Not Applicable
Antibiotic Treatment Versus no Therapy in Kidney Transplant Recipients With Asymptomatic BacteriuriaAsymptomatic BacteriuriaPyelonephritisNCT01771432Núria Sabé Fernàndez200
Completed
Not Applicable
Transplant Renal Artery Intervention: Analysis of a 11-Year Single Center ExperienceFor trials without interventionpercutaneous transluminal renal angioplasty (PTRA),percutaneous transluminal renal angioplasty with stenting (PTRAS),transplant renal artery stenosis (TRAS),long-term outcomeTCTR20200626002o65