ClinicalTrials.gg
CompletedNCT01871753BiRTUpdated Jul 18, 2019

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

A Phase 4 interventional study of Anti-Infective Agents in Asymptomatic Bacteriuria, Bacteriuria and Urinary Tract Infections, sponsored by Erasme University Hospital. Completed at 15 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-18.

Sponsored by Erasme University Hospital · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
198
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the detailed description

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

02

Conditions studied

  • Asymptomatic Bacteriuria
  • Bacteriuria
  • Urinary Tract Infections
  • Kidney Transplantation
03

In context

Bacteriuria

51 studies on the registry are indexed under Bacteriuria; 3 are open to participants now.

This study's planned enrollment of 198 is above the median of 100 across 37 interventional studies indexed under Bacteriuria.

Browse Bacteriuria studies →

Lead sponsor

Erasme University Hospital is the lead sponsor of 181 studies on the registry; 35 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Kidney transplant recipient with asymptomatic bacteriuria after the first two months post-transplantation

Exclusion criteria

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 (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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
198 participants (estimated)

Study arms

  • Experimental
    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).

    Other: Anti-Infective Agents

  • No intervention
    No treatment

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

Interventions

  • OtherAnti-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)

    Also known as: 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

06

What researchers measure

Primary outcomes

  1. cumulative incidence of a first episode of symptomatic urinary tract infection

    Time frame: 12 months

Secondary outcomes

  1. incidence of a first episode of pyelonephritis

    Time frame: 12 months

  2. clearance of asymptomatic bacteriuria

    Time frame: 12 months

  3. occurrence of new episodes of asymptomatic bacteriuria

    Time frame: 12 months

  4. graft function/graft survival

    Time frame: 12 months

  5. incidence of graft rejection

    Time frame: 12 months

  6. patient survival

    Time frame: 12 months

  7. utility of a control urine culture for diagnosis of asymptomatic bacteriuria in kidney transplant recipients

    Time frame: 12 months

  8. level of antimicrobial resistance in bacteria responsible for symptomatic urinary tract infections

    Time frame: 12 months

  9. total number of days of antimicrobial therapy

    Time frame: 12 months

  10. cost of antimicrobial treatment for asymptomatic bacteriuria and symptomatic urinary tract infection

    Time frame: 12 months

  11. number of hospitalizations for asymptomatic bacteriuria and symptomatic urinary tract infection treatment

    Time frame: 12 months

  12. total number of symptomatic urinary tract infections in both groups

    Time frame: 12 months

07

Study locations

15 sites
  • Universitair Ziekenhuis Antwerpen
    Antwerpen, 2650, Belgium
  • Centre Hospitalier Epicura
    Baudour, 7331, Belgium
  • Centre Hospitalier Universitaire Brugmann
    Brussels, 1020, Belgium
  • Hôpital Universitaire Erasme
    Brussels, 1070, Belgium
  • Universitair Ziekenhuis Brussel - Vrije Universiteit Brussel
    Brussels, 1090, Belgium
  • Centre Hospitalier Universitaire de Charleroi
    Charleroi, 6110, Belgium
  • Universitair Ziekenhuis Gent
    Gent, 9000, Belgium
  • Centre Hospitalier Universitaire de Liège
    Liège, 4000, Belgium
  • Groupe Henri Mondor-Albert Chenevier, Assistance Publique-Hôpitaux de Paris
    Créteil, 94000, France
  • Centre Hospitalier Régional Universitaire de Lille
    Lille, 59037, France
  • Centre Hospitalier Universitaire de Nantes
    Nantes, 44000, France
  • Department of Kidney Transplantation, Hôpital Necker Enfants-Malades, Université de Paris Descartes, APHP
    Paris, 75015, France
  • Hôpital Tenon, Assistance Publique-Hôpitaux de Paris
    Paris, 75020, France
  • Centre Hospitalier Universitaire de Saint-Étienne
    Saint-Étienne, 42055, France
  • Centre Hospitalier Universitaire Rangueil
    Toulouse, 31059, France
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2014 to primary completion in Jul 2019, 63 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 31, 2013
First posted
Jun 7, 2013
StartActual
Apr 2014
Primary completionActual
Jul 2019
CompletionActual
Jul 2019
Last update
Jul 18, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 18, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01871753
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
Responsible party
Julien Coussement, MD (Julien Coussement, MD, Erasme University Hospital) — Principal investigator
First posted
Jun 7, 2013
Start date
Apr 2014
Primary completion
Jul 2019
Completion
Jul 2019
Last update
Jul 18, 2019

Study contacts

Julien Coussement, MD
study director · Hôpital Universitaire Erasme, Brussels, Belgium

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion