Relevance of the Urine Bacterial Culture Performed Before Double J Ablation for Post-operative Urinary Tract Infection Prevention (AblaJ)
Primary Purpose
Urinary Infection
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
CBEU
No CBEU
Sponsored by
About this trial
This is an interventional diagnostic trial for Urinary Infection
Eligibility Criteria
Inclusion Criteria:
- Participant ≥ 18 years of age
- Scheduled to have a double J catheter ablation
- Participants covered by or entitled to social security
- Written informed consent obtained from the participant
- Ability for participant to comply with the requirements of the study
Exclusion Criteria:
- Patients already receiving antibiotics other than febrile renal colic antibiotics
- Study interventions contraindications
- Pregnancy, breastfeeding
- Patient under tutorship or curators
- Deprivation of liberty
Sites / Locations
- BRUYERERecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
No systematic CBEU
Systematic CBEU
Arm Description
Patients will not have bacterial culture performed before double J removal.
Patients will have a systematic urine culture performed before double J removal.
Outcomes
Primary Outcome Measures
Incidence of infection
Incidence over a month period of post-ablation symptomatic urinary infection defined by the presence of symptoms validated by an adjudication committee (urine burning, fever, urgencies… associated to a significant bacteriuria) - each patient will be contacted by phone at month 1 (± 5 days) and will be asked to contact us in case of suspicion of urinary infection.
Secondary Outcome Measures
Incidence of bacteriuria measured by CBEU
Incidence of post-ablation bacteriuria (urosepsis and antibiotic use) in different groups of patients (reason of the stent, duration of the insertion, previous infection, immunodepression….) in the 1 month post-ablation period
Description of the resistance type of pre-operative distribution of bacteriuria by CBEU
Epidemiology of the resistance type of pre-operative bacteriuria
Description of the pre-operative distribution of bacteriuria by CBEU
Epidemiology of pre-operative bacteriuria
Description of the resistance type of post operative distribution of bacteriuria by CBEU
Epidemiology of the resistance type of post-ablation bacteriuria
Description of the post operative distribution of bacteriuria by CBEU
Epidemiology of post-ablation bacteriuria
Composition of microbiome by bacterial urinary analysis
Comparison of the pre-operative urinary microbiome to the post-ablation urinary microbiome in patient with post-ablation infection.
Health-economic outcome
Proportion of incremental costs-effects pairs that lies in the non-inferiority area, for various values of economic non-inferiority
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04913753
Brief Title
Relevance of the Urine Bacterial Culture Performed Before Double J Ablation for Post-operative Urinary Tract Infection Prevention
Acronym
AblaJ
Official Title
Relevance of the Urine Bacterial Culture Performed Before Double J Ablation for Post-operative Urinary Tract Infection Prevention
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 10, 2021 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
October 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Tours
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The value of cytobacteriological examination of urine (CBEU) before double J catheter removal has not been demonstrated. The aim of this study is to define the interest of this CBEU.
Detailed Description
Double J stents are ureteral catheters that allow urine to flow from the kidney without difficulty. These catheters protect the ureterovesical anastomosis of a renal transplant or reduce the postoperative oedema, for example after stone removal by ureteroscopy. These catheters are removed in an outpatient setting under local anaesthesia. Post ablation infections of double J catheters have been poorly studied but their incidence varied according to the populations and the definition used (10 to 54% for colonization, 1 to 10% for symptomatic infection). The national and international guidelines advocate a routine urine bacterial culture (UBC) before double J catheter removal as the procedure is in contact with urine; but there is no evidence of its interest. In case of positivity of this culture, it is recommended to delay the intervention or, what is more often chosen, to treat with antibiotic to cover the procedure. Investigators can thus ask 2 questions: is it rightful to withdraw a double J removal while the UBC is falsely negative and in case of a positive bacterial culture is there an increased risk of post-ablation infection?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Infection
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
No systematic CBEU
Arm Type
Experimental
Arm Description
Patients will not have bacterial culture performed before double J removal.
Arm Title
Systematic CBEU
Arm Type
Active Comparator
Arm Description
Patients will have a systematic urine culture performed before double J removal.
Intervention Type
Procedure
Intervention Name(s)
CBEU
Intervention Description
Patients in the control group will have bacterial culture and double J removal will be performed as usual. .
Intervention Type
Procedure
Intervention Name(s)
No CBEU
Intervention Description
Patients in the experimental group will have bacterial culture and double J removal will be performed as usual. .
Primary Outcome Measure Information:
Title
Incidence of infection
Description
Incidence over a month period of post-ablation symptomatic urinary infection defined by the presence of symptoms validated by an adjudication committee (urine burning, fever, urgencies… associated to a significant bacteriuria) - each patient will be contacted by phone at month 1 (± 5 days) and will be asked to contact us in case of suspicion of urinary infection.
Time Frame
1 month post double J removal
Secondary Outcome Measure Information:
Title
Incidence of bacteriuria measured by CBEU
Description
Incidence of post-ablation bacteriuria (urosepsis and antibiotic use) in different groups of patients (reason of the stent, duration of the insertion, previous infection, immunodepression….) in the 1 month post-ablation period
Time Frame
1 month post double J removal
Title
Description of the resistance type of pre-operative distribution of bacteriuria by CBEU
Description
Epidemiology of the resistance type of pre-operative bacteriuria
Time Frame
10 days to 4 days before double J removal
Title
Description of the pre-operative distribution of bacteriuria by CBEU
Description
Epidemiology of pre-operative bacteriuria
Time Frame
10 days to 4 days before double J removal
Title
Description of the resistance type of post operative distribution of bacteriuria by CBEU
Description
Epidemiology of the resistance type of post-ablation bacteriuria
Time Frame
1 month after double J removal
Title
Description of the post operative distribution of bacteriuria by CBEU
Description
Epidemiology of post-ablation bacteriuria
Time Frame
1 month after double J removal
Title
Composition of microbiome by bacterial urinary analysis
Description
Comparison of the pre-operative urinary microbiome to the post-ablation urinary microbiome in patient with post-ablation infection.
Time Frame
1 month post double J removal
Title
Health-economic outcome
Description
Proportion of incremental costs-effects pairs that lies in the non-inferiority area, for various values of economic non-inferiority
Time Frame
1 month post double J removal
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participant ≥ 18 years of age
Scheduled to have a double J catheter ablation
Participants covered by or entitled to social security
Written informed consent obtained from the participant
Ability for participant to comply with the requirements of the study
Exclusion Criteria:
Patients already receiving antibiotics other than urological reasons and transplanted patients
Study interventions contraindications
Pregnancy, breastfeeding
Patient under tutorship or curators
Deprivation of liberty
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Franck BRUYERE, PhD
Phone
+33 2 34 38 95 63
Email
f.bruyere@chu-tours.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Elodie MOUSSET
Phone
+33 2 47 47 46 65
Email
e.mousset@ch-tours.fr
Facility Information:
Facility Name
BRUYERE
City
Tours
ZIP/Postal Code
37044
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Franck BRUYERE
12. IPD Sharing Statement
Learn more about this trial
Relevance of the Urine Bacterial Culture Performed Before Double J Ablation for Post-operative Urinary Tract Infection Prevention
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