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

NCT ID: NCT01871753

Last Updated: 2019-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 198 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2019-07-31

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.

Conditions

Asymptomatic Bacteriuria; Bacteriuria; Urinary Tract Infections; Kidney Transplantation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Antibiotics

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).

Group Type: EXPERIMENTAL

Anti-Infective Agents

Intervention Type: OTHER

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)

No treatment

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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)

Intervention Type: OTHER

Other Intervention Names

Anti-Infective Agents: not applicable - no specific agent; The choice of antimicrobial agent is at the discretion of the physician, and is based on the antibiogram results

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Lille

OTHER

Sponsor Role: collaborator

Universitair Ziekenhuis Brussel

OTHER

Sponsor Role: collaborator

Hôpital Necker Enfants-Malades, Université de Paris Descartes, APHP, France

UNKNOWN

Sponsor Role: collaborator

Centre Hospitalier Universitaire Brugmann

OTHER

Sponsor Role: collaborator

Centre Hospitalier Universitaire de Charleroi

OTHER

Sponsor Role: collaborator

University Ghent

OTHER

Sponsor Role: collaborator

Centre Hospitalier Epicura, Belgium

UNKNOWN

Sponsor Role: collaborator

University of Liege

OTHER

Sponsor Role: collaborator

Nantes University Hospital

OTHER

Sponsor Role: collaborator

Erasme University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Julien Coussement, MD

Julien Coussement, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Julien Coussement, MD

Role: STUDY_DIRECTOR

Hôpital Universitaire Erasme, Brussels, Belgium

Locations

Universitair Ziekenhuis Antwerpen

Antwerp, , 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

Ghent, , Belgium

Centre Hospitalier Universitaire de Liège

Liège, , Belgium

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-Etienne, , France

Centre Hospitalier Universitaire Rangueil

Toulouse, , France

Countries

Belgium; France

Other Identifiers

2012-003857-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

BiRT study

Identifier Type: -

Identifier Source: org_study_id