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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01871753
Other study ID # BiRT study
Secondary ID 2012-003857-26
Status Completed
Phase Phase 4
First received
Last updated
Start date April 2014
Est. completion date July 2019

Study information

Verified date July 2019
Source Erasme University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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


Recruitment information / eligibility

Status Completed
Enrollment 198
Est. completion date July 2019
Est. primary completion date July 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Other:
Anti-Infective Agents
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)

Locations

Country Name City State
Belgium Universitair Ziekenhuis Antwerpen Antwerpen
Belgium Centre Hospitalier Epicura Baudour
Belgium Centre Hospitalier Universitaire Brugmann Brussels
Belgium Hôpital Universitaire Erasme Brussels
Belgium Universitair Ziekenhuis Brussel - Vrije Universiteit Brussel Brussels
Belgium Centre Hospitalier Universitaire de Charleroi Charleroi
Belgium Universitair Ziekenhuis Gent Gent
Belgium Centre Hospitalier Universitaire de Liège Liège
France Groupe Henri Mondor-Albert Chenevier, Assistance Publique-Hôpitaux de Paris Créteil
France Centre Hospitalier Régional Universitaire de Lille Lille
France Centre Hospitalier Universitaire de Nantes Nantes
France Department of Kidney Transplantation, Hôpital Necker Enfants-Malades, Université de Paris Descartes, APHP Paris
France Hôpital Tenon, Assistance Publique-Hôpitaux de Paris Paris
France Centre Hospitalier Universitaire de Saint-Étienne Saint-Étienne
France Centre Hospitalier Universitaire Rangueil Toulouse

Sponsors (10)

Lead Sponsor Collaborator
Erasme University Hospital Centre Hospitalier Epicura, Belgium, Centre Hospitalier Universitaire Brugmann, Centre Hospitalier Universitaire de Charleroi, Hôpital Necker Enfants-Malades, Université de Paris Descartes, APHP, France, Nantes University Hospital, Universitair Ziekenhuis Brussel, University Ghent, University Hospital, Lille, University of Liege

Countries where clinical trial is conducted

Belgium,  France, 

Outcome

Type Measure Description Time frame Safety issue
Primary cumulative incidence of a first episode of symptomatic urinary tract infection 12 months
Secondary incidence of a first episode of pyelonephritis 12 months
Secondary clearance of asymptomatic bacteriuria 12 months
Secondary occurrence of new episodes of asymptomatic bacteriuria 12 months
Secondary graft function/graft survival 12 months
Secondary incidence of graft rejection 12 months
Secondary patient survival 12 months
Secondary utility of a control urine culture for diagnosis of asymptomatic bacteriuria in kidney transplant recipients 12 months
Secondary level of antimicrobial resistance in bacteria responsible for symptomatic urinary tract infections 12 months
Secondary total number of days of antimicrobial therapy 12 months
Secondary cost of antimicrobial treatment for asymptomatic bacteriuria and symptomatic urinary tract infection 12 months
Secondary number of hospitalizations for asymptomatic bacteriuria and symptomatic urinary tract infection treatment 12 months
Secondary total number of symptomatic urinary tract infections in both groups 12 months
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