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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Erasme University Hospital
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
Universitair Ziekenhuis Gent, Belgium
Centre Hospitalier Epicura, Belgium
University Hospital of Liege
Nantes University Hospital
Information provided by (Responsible Party):
Julien Coussement, MD, Erasme University Hospital
ClinicalTrials.gov Identifier:
NCT01871753
First received: May 31, 2013
Last updated: September 23, 2014
Last verified: September 2014
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Erasme University Hospital:

Primary Outcome Measures:
  • cumulative incidence of a first episode of symptomatic urinary tract infection [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • incidence of a first episode of pyelonephritis [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • clearance of asymptomatic bacteriuria [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • occurrence of new episodes of asymptomatic bacteriuria [ Time Frame: 12 months ]
  • graft function/graft survival [ Time Frame: 12 months ]
  • incidence of graft rejection [ Time Frame: 12 months ]
  • patient survival [ Time Frame: 12 months ]
  • utility of a control urine culture for diagnosis of asymptomatic bacteriuria in kidney transplant recipients [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • level of antimicrobial resistance in bacteria responsible for symptomatic urinary tract infections [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • total number of days of antimicrobial therapy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • cost of antimicrobial treatment for asymptomatic bacteriuria and symptomatic urinary tract infection [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • number of hospitalizations for asymptomatic bacteriuria and symptomatic urinary tract infection treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • total number of symptomatic urinary tract infections in both groups [ Time Frame: 12 months ]

Estimated Enrollment: 198
Study Start Date: January 2014
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01871753

Contacts
Contact: Julien Coussement, MD 003225553111 juliencoussement@gmail.com

Locations
Belgium
Universitair Ziekenhuis Antwerpen Recruiting
Antwerpen, Belgium, 2650
Contact: Daniel Abramowicz, MD, PhD    +32.3.821.34.35    dabram@ulb.ac.be   
Principal Investigator: Daniel Abramowicz, MD, PhD         
Sub-Investigator: Jean-Louis Bosmans, MD, PhD         
Sub-Investigator: Herman Goossens, MD, PhD         
Centre Hospitalier Epicura Recruiting
Baudour, Belgium, 7331
Contact: Lidia Ghisdal, MD, PhD    003265768111    lghisdal@yahoo.com   
Principal Investigator: Lidia Ghisdal, MD, PhD         
Centre Hospitalier Universitaire Brugmann Recruiting
Brussels, Belgium, 1020
Contact: Mireille Kianda, MD    +32.2.477.26.41    mireille.kianda@erasme.ulb.ac.be   
Sub-Investigator: Mireille Kianda, MD         
Universitair Ziekenhuis Brussel - Vrije Universiteit Brussel Recruiting
Brussels, Belgium, 1090
Contact: Karl M Wissing, MD, PhD    +32.2.477.60.55    karlmartin.wissing@uzbrussel.be   
Principal Investigator: Karl M Wissing, MD, PhD         
Hôpital Universitaire Erasme Recruiting
Brussels, Belgium, 1070
Contact: Julien Coussement, MD    +32.2.555.30.49    julien.coussement@erasme.ulb.ac.be   
Principal Investigator: Julien Coussement, MD         
Sub-Investigator: Frédérique Jacobs, MD, PhD         
Sub-Investigator: Sandrine Roisin, MD         
Sub-Investigator: Nilufer Broeders, MD         
Centre Hospitalier Universitaire de Charleroi Recruiting
Charleroi, Belgium, 6110
Contact: Philippe Madhoun, MD    +32.7.192.11.82    philippe.madhoun@chu-charleroi.be   
Sub-Investigator: Philippe Madhoun, MD         
Universitair Ziekenhuis Gent Recruiting
Gent, Belgium, 9000
Contact: Patrick Peeters, MD    +32.9.332.27.42    patrick.peeters@ugent.be   
Principal Investigator: Patrick Peeters, MD, PhD         
Sub-Investigator: Steven Van Laecke, MD         
Centre Hospitalier Universitaire de Liège Recruiting
Liège, Belgium, 4000
Contact: Laurent Weekers, MD    +32.4.366.74.05    l.weekers@chu.ulg.ac.be   
Principal Investigator: Laurent Weekers, MD         
France
Centre Hospitalier Régional Universitaire de Lille Not yet recruiting
Lille, France, 59037
Contact: Marc Hazzan, MD, PhD    +33.3.20.44.67.70    mhazzan@gmail.com   
Principal Investigator: Marc Hazzan, MD, PhD         
Centre Hospitalier Universitaire de Nantes Not yet recruiting
Nantes, France, 44000
Contact: Vianney Charpy, MD       vianney.charpy@chu-nantes.fr   
Principal Investigator: Vianney Charpy, MD         
Sub-Investigator: Magali Giral, MD, PhD         
Department of Kidney Transplantation, Hôpital Necker Enfants-Malades, Université de Paris Descartes, APHP Not yet recruiting
Paris, France, 75015
Contact: Anne Scemla, MD    +33.1.44.49.54.41    anne.scemla@nck.aphp.fr   
Principal Investigator: Anne Scemla, MD         
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
Universitair Ziekenhuis Gent, Belgium
Centre Hospitalier Epicura, Belgium
University Hospital of Liege
Nantes University Hospital
Investigators
Study Director: Julien Coussement, MD Hôpital Universitaire Erasme, Brussels, Belgium
  More Information

Additional Information:
No publications provided

Responsible Party: Julien Coussement, MD, Erasme University Hospital
ClinicalTrials.gov Identifier: NCT01871753     History of Changes
Other Study ID Numbers: BiRT study, 2012-003857-26
Study First Received: May 31, 2013
Last Updated: September 23, 2014
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
France: Agence Nationale de Sécurité du Médicament et des produits de santé

Additional relevant MeSH terms:
Urinary Tract Infections
Infection
Communicable Diseases
Bacteriuria
Urologic Diseases
Anti-Infective Agents
Anti-Bacterial Agents
Antibiotics, Antitubercular
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on September 30, 2014