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

Kidney Transplantation Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01871753
• Other study ID #: BiRT study
• Secondary ID: 2012-003857-26
• Status: Completed
• Phase: Phase 4
• Start date: April 2014
• Est. completion date: July 2019

Study information

• Verified date: July 2019
• Source: Erasme University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: July 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asymptomatic Bacteriuria
• Bacteriuria
• Communicable Diseases
• Infection
• Kidney Transplantation
• Urinary Tract Infections

Intervention

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)

Locations

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

Sponsors (10)

Lead Sponsor	Collaborator
Erasme University Hospital	Centre Hospitalier Epicura, Belgium, Centre Hospitalier Universitaire Brugmann, Centre Hospitalier Universitaire de Charleroi, Hôpital Necker Enfants-Malades, Université de Paris Descartes, APHP, France, Nantes University Hospital, Universitair Ziekenhuis Brussel, University Ghent, University Hospital, Lille, University of Liege

Countries where clinical trial is conducted

Belgium,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cumulative incidence of a first episode of symptomatic urinary tract infection		12 months
Secondary	incidence of a first episode of pyelonephritis		12 months
Secondary	clearance of asymptomatic bacteriuria		12 months
Secondary	occurrence of new episodes of asymptomatic bacteriuria		12 months
Secondary	graft function/graft survival		12 months
Secondary	incidence of graft rejection		12 months
Secondary	patient survival		12 months
Secondary	utility of a control urine culture for diagnosis of asymptomatic bacteriuria in kidney transplant recipients		12 months
Secondary	level of antimicrobial resistance in bacteria responsible for symptomatic urinary tract infections		12 months
Secondary	total number of days of antimicrobial therapy		12 months
Secondary	cost of antimicrobial treatment for asymptomatic bacteriuria and symptomatic urinary tract infection		12 months
Secondary	number of hospitalizations for asymptomatic bacteriuria and symptomatic urinary tract infection treatment		12 months
Secondary	total number of symptomatic urinary tract infections in both groups		12 months

External Links

•   trial website