search
Back to results

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 (BiRT)

Primary Purpose

Asymptomatic Bacteriuria, Bacteriuria, Urinary Tract Infections

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Anti-Infective Agents
Sponsored by
Erasme University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asymptomatic Bacteriuria

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Antibiotics

No treatment

Arm Description

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 antibiotics delivered in case of asymptomatic bacteriuria, independently of the number of asymptomatic episodes.

Outcomes

Primary Outcome Measures

cumulative incidence of a first episode of symptomatic urinary tract infection

Secondary Outcome Measures

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

Full Information

First Posted
May 31, 2013
Last Updated
July 16, 2019
Sponsor
Erasme University Hospital
Collaborators
University Hospital, Lille, Universitair Ziekenhuis Brussel, Hôpital Necker Enfants-Malades, Université de Paris Descartes, APHP, France, Centre Hospitalier Universitaire Brugmann, Centre Hospitalier Universitaire de Charleroi, University Ghent, Centre Hospitalier Epicura, Belgium, University of Liege, Nantes University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01871753
Brief Title
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
Acronym
BiRT
Official Title
The Bacteriuria in Renal Transplantation (BiRT) Study: A Prospective, Randomized, Parallel-group, Multicenter, Open-label, Superiority Trial Comparing Antibiotics Versus no Treatment in the Prevention of Symptomatic Urinary Tract Infection in Kidney Transplant Recipients With Asymptomatic Bacteriuria
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
April 2014 (Actual)
Primary Completion Date
July 2019 (Actual)
Study Completion Date
July 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erasme University Hospital
Collaborators
University Hospital, Lille, Universitair Ziekenhuis Brussel, Hôpital Necker Enfants-Malades, Université de Paris Descartes, APHP, France, Centre Hospitalier Universitaire Brugmann, Centre Hospitalier Universitaire de Charleroi, University Ghent, Centre Hospitalier Epicura, Belgium, University of Liege, Nantes University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asymptomatic Bacteriuria, Bacteriuria, Urinary Tract Infections, Kidney Transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
198 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Antibiotics
Arm Type
Experimental
Arm Description
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).
Arm Title
No treatment
Arm Type
No Intervention
Arm Description
no antibiotics delivered in case of asymptomatic bacteriuria, independently of the number of asymptomatic episodes.
Intervention Type
Other
Intervention Name(s)
Anti-Infective Agents
Other Intervention Name(s)
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
Intervention Description
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)
Primary Outcome Measure Information:
Title
cumulative incidence of a first episode of symptomatic urinary tract infection
Time Frame
12 months
Secondary Outcome Measure Information:
Title
incidence of a first episode of pyelonephritis
Time Frame
12 months
Title
clearance of asymptomatic bacteriuria
Time Frame
12 months
Title
occurrence of new episodes of asymptomatic bacteriuria
Time Frame
12 months
Title
graft function/graft survival
Time Frame
12 months
Title
incidence of graft rejection
Time Frame
12 months
Title
patient survival
Time Frame
12 months
Title
utility of a control urine culture for diagnosis of asymptomatic bacteriuria in kidney transplant recipients
Time Frame
12 months
Title
level of antimicrobial resistance in bacteria responsible for symptomatic urinary tract infections
Time Frame
12 months
Title
total number of days of antimicrobial therapy
Time Frame
12 months
Title
cost of antimicrobial treatment for asymptomatic bacteriuria and symptomatic urinary tract infection
Time Frame
12 months
Title
number of hospitalizations for asymptomatic bacteriuria and symptomatic urinary tract infection treatment
Time Frame
12 months
Title
total number of symptomatic urinary tract infections in both groups
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julien Coussement, MD
Organizational Affiliation
Hôpital Universitaire Erasme, Brussels, Belgium
Official's Role
Study Director
Facility Information:
Facility Name
Universitair Ziekenhuis Antwerpen
City
Antwerpen
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Centre Hospitalier Epicura
City
Baudour
ZIP/Postal Code
7331
Country
Belgium
Facility Name
Centre Hospitalier Universitaire Brugmann
City
Brussels
ZIP/Postal Code
1020
Country
Belgium
Facility Name
Hôpital Universitaire Erasme
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Universitair Ziekenhuis Brussel - Vrije Universiteit Brussel
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Centre Hospitalier Universitaire de Charleroi
City
Charleroi
ZIP/Postal Code
6110
Country
Belgium
Facility Name
Universitair Ziekenhuis Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Centre Hospitalier Universitaire de Liège
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Groupe Henri Mondor-Albert Chenevier, Assistance Publique-Hôpitaux de Paris
City
Créteil
ZIP/Postal Code
94000
Country
France
Facility Name
Centre Hospitalier Régional Universitaire de Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Centre Hospitalier Universitaire de Nantes
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
Department of Kidney Transplantation, Hôpital Necker Enfants-Malades, Université de Paris Descartes, APHP
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Hôpital Tenon, Assistance Publique-Hôpitaux de Paris
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
Centre Hospitalier Universitaire de Saint-Étienne
City
Saint-Étienne
ZIP/Postal Code
42055
Country
France
Facility Name
Centre Hospitalier Universitaire Rangueil
City
Toulouse
ZIP/Postal Code
31059
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs