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Completed

NCT Number: NCT01871753

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

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

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Key information

Conditions

Asymptomatic Bacteriuria Bacteriuria Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Kidney Transplantation Male Urogenital Diseases Urinary Tract Infections Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Universitair Ziekenhuis Antwerpen, Antwerp, Belgium

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anti-Infective Agents

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)

Other 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

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

Sponsors and collaborators

Lead sponsor

Erasme University Hospital

Other

Collaborators

  • Centre Hospitalier Epicura, Belgium
  • Centre Hospitalier Universitaire Brugmann
  • Centre Hospitalier Universitaire de Charleroi
  • Hôpital Necker-Enfants Malades
  • Nantes University Hospital
  • Universitair Ziekenhuis Brussel
  • University Ghent
  • University Hospital, Lille
  • University of Liege

Registry information

Official study 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

Acronym: BiRT

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Jun 7, 2013
Registry last updated
Jul 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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