Asymptomatic BacteriuriaPhase 4BiRTNCT01871753
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 study testing Anti-Infective Agents in people with Asymptomatic Bacteriuria and Bacteriuria, run by Erasme University Hospital at 15 sites in 2 countries.
Trial summary
The purpose of this study is to compare antibiotics versus no-treatment in kidney transplant recipients with asymptomatic bacteriuria. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asymptomatic Bacteriuria, Bacteriuria, Urinary Tract Infections
- What is being tested?
- Anti-Infective Agents
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 15 sitesin 2 countries
- Study dates
- Apr 2014to Jul 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Kidney transplant recipient with asymptomatic bacteriuria after the first two months post-transplantation
Who cannot join
- 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)
Show all 12Show fewer
- 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
Trial locations and contacts
15 sites in 2 countries.
15 sites in 2 countries
Belgium8 sites
Universitair Ziekenhuis Antwerpen
Antwerp, 2650
Centre Hospitalier Epicura
Baudour, 7331
Centre Hospitalier Universitaire Brugmann
Brussels, 1020
Hôpital Universitaire Erasme
Brussels, 1070
Universitair Ziekenhuis Brussel - Vrije Universiteit Brussel
Brussels, 1090
Centre Hospitalier Universitaire de Charleroi
Charleroi, 6110
Universitair Ziekenhuis Gent
Ghent, 9000
Centre Hospitalier Universitaire de Liège
Liège, 4000
France7 sites
Groupe Henri Mondor-Albert Chenevier, Assistance Publique-Hôpitaux de Paris
Créteil, 94000
Centre Hospitalier Régional Universitaire de Lille
Lille, 59037
Centre Hospitalier Universitaire de Nantes
Nantes, 44000
Department of Kidney Transplantation, Hôpital Necker Enfants-Malades, Université de Paris Descartes, APHP
Paris, 75015
Hôpital Tenon, Assistance Publique-Hôpitaux de Paris
Paris, 75020
Centre Hospitalier Universitaire de Saint-Étienne
Saint-Etienne, 42055
Centre Hospitalier Universitaire Rangueil
Toulouse, 31059
About this study
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
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.
- Being tested
- Anti-Infective Agents
- Medical subject headings
- Bacteriuria, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-Infective AgentsOther
Also called 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
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)
| Study group | Role | What they receive |
|---|---|---|
| Antibiotics | Experimental | 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). Receives: Other: Anti-Infective Agents |
| No treatment | No intervention | no antibiotics delivered in case of asymptomatic bacteriuria, independently of the number of asymptomatic episodes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
cumulative incidence of a first episode of symptomatic urinary tract infection
Measured: 12 months
Secondary outcomes (12)
incidence of a first episode of pyelonephritis
Measured: 12 months
clearance of asymptomatic bacteriuria
Measured: 12 months
occurrence of new episodes of asymptomatic bacteriuria
Measured: 12 months
graft function/graft survival
Measured: 12 months
incidence of graft rejection
Measured: 12 months
patient survival
Measured: 12 months
utility of a control urine culture for diagnosis of asymptomatic bacteriuria in kidney transplant recipients
Measured: 12 months
level of antimicrobial resistance in bacteria responsible for symptomatic urinary tract infections
Measured: 12 months
total number of days of antimicrobial therapy
Measured: 12 months
cost of antimicrobial treatment for asymptomatic bacteriuria and symptomatic urinary tract infection
Measured: 12 months
number of hospitalizations for asymptomatic bacteriuria and symptomatic urinary tract infection treatment
Measured: 12 months
total number of symptomatic urinary tract infections in both groups
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2013 (estimated)
- Study startApr 2014
- Primary completionJul 2019
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asymptomatic BacteriuriaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Lille, Universitair Ziekenhuis Brussel, Hôpital Necker-Enfants Malades, Centre Hospitalier Universitaire Brugmann, Centre Hospitalier Universitaire de Charleroi, University Ghent, Centre Hospitalier Epicura, Belgium, University of Liege, Nantes University Hospital
- Responsible party
- Principal investigator, Julien Coussement, MD, Erasme University Hospital
- Investigators
- Julien Coussement, MD, Study director, Hôpital Universitaire Erasme, Brussels, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01871753
- Sponsor's protocol ID
- BiRT study
- Other IDs
- 2012-003857-26
- Acronym
- BiRT
- Status last verified
- Jul 2019
- First submitted
- 31 May 2013
- Last updated
- 18 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01871753
- Acronym / sponsor ID
- BiRT / BiRT study
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Collaborators
- University Hospital, Lille, Universitair Ziekenhuis Brussel, Hôpital Necker-Enfants Malades, Centre Hospitalier Universitaire Brugmann, Centre Hospitalier Universitaire de Charleroi, University Ghent, Centre Hospitalier Epicura, Belgium, University of Liege, Nantes University Hospital
- Study start
- Apr 2014 (actual)
- Primary completion
- Jul 2019 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 7 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare antibiotics versus no-treatment in kidney transplant recipients with asymptomatic bacteriuria.
Detailed description
The BiRT trial investigators would be interested to collaborate with some additional hospitals, particularly centers having high level of antimicrobial resistance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antibiotics | Experimental | Other: Anti-Infective Agents10 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). |
| No treatment | No intervention | –no antibiotics delivered in case of asymptomatic bacteriuria, independently of the number of asymptomatic episodes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Kidney transplant recipient with asymptomatic bacteriuria after the first two months post-transplantation
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anti-Infective AgentsAlso: 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 results10 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 | Antibiotics |
Primary outcome
cumulative incidence of a first episode of symptomatic urinary tract infection
Time frame: 12 months
12 secondary outcomes
incidence of a first episode of pyelonephritis
Time frame: 12 months
clearance of asymptomatic bacteriuria
Time frame: 12 months
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
level of antimicrobial resistance in bacteria responsible for symptomatic urinary tract infections
Time frame: 12 months
total number of days of antimicrobial therapy
Time frame: 12 months
cost of antimicrobial treatment for asymptomatic bacteriuria and symptomatic urinary tract infection
Time frame: 12 months
number of hospitalizations for asymptomatic bacteriuria and symptomatic urinary tract infection treatment
Time frame: 12 months
total number of symptomatic urinary tract infections in both groups
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julien Coussement, MD study director
Hôpital Universitaire Erasme, Brussels, Belgium
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Anti-Infective Agents in people with Asymptomatic Bacteriuria and Bacteriuria, run by Erasme University Hospital at 15 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Belgium, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cumulative incidence of a first episode of symptomatic urinary tract infection (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2019.