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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)

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ClinicalTrials.gov Identifier: NCT01871753
Recruitment Status : Completed
First Posted : June 7, 2013
Last Update Posted : July 18, 2019
Sponsor:
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
Information provided by (Responsible Party):
Julien Coussement, MD, Erasme University Hospital

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

Condition or disease Intervention/treatment Phase
Asymptomatic Bacteriuria Bacteriuria Urinary Tract Infections Kidney Transplantation Other: Anti-Infective Agents Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 198 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 2014
Actual Primary Completion Date : July 2019
Actual Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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

No Intervention: No treatment
no antibiotics delivered in case of asymptomatic bacteriuria, independently of the number of asymptomatic episodes.



Primary Outcome Measures :
  1. cumulative incidence of a first episode of symptomatic urinary tract infection [ Time Frame: 12 months ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01871753


Locations
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Belgium
Universitair Ziekenhuis Antwerpen
Antwerpen, Belgium, 2650
Centre Hospitalier Epicura
Baudour, Belgium, 7331
Centre Hospitalier Universitaire Brugmann
Brussels, Belgium, 1020
Hôpital Universitaire Erasme
Brussels, Belgium, 1070
Universitair Ziekenhuis Brussel - Vrije Universiteit Brussel
Brussels, Belgium, 1090
Centre Hospitalier Universitaire de Charleroi
Charleroi, Belgium, 6110
Universitair Ziekenhuis Gent
Gent, Belgium, 9000
Centre Hospitalier Universitaire de Liège
Liège, Belgium, 4000
France
Groupe Henri Mondor-Albert Chenevier, Assistance Publique-Hôpitaux de Paris
Créteil, France, 94000
Centre Hospitalier Régional Universitaire de Lille
Lille, France, 59037
Centre Hospitalier Universitaire de Nantes
Nantes, France, 44000
Department of Kidney Transplantation, Hôpital Necker Enfants-Malades, Université de Paris Descartes, APHP
Paris, France, 75015
Hôpital Tenon, Assistance Publique-Hôpitaux de Paris
Paris, France, 75020
Centre Hospitalier Universitaire de Saint-Étienne
Saint-Étienne, France, 42055
Centre Hospitalier Universitaire Rangueil
Toulouse, France, 31059
Sponsors and Collaborators
Erasme University Hospital
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
Investigators
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Study Director: Julien Coussement, MD Hôpital Universitaire Erasme, Brussels, Belgium

Additional Information:
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Responsible Party: Julien Coussement, MD, Erasme University Hospital
ClinicalTrials.gov Identifier: NCT01871753     History of Changes
Other Study ID Numbers: BiRT study
2012-003857-26 ( EudraCT Number )
First Posted: June 7, 2013    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Urinary Tract Infections
Bacteriuria
Urologic Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents