- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06503588
Ureteral Stent Exchange Abstention in Urinary Tract Infections (JJ-change-UTI)
Ureteral Stent Exchange Abstention in Urinary Tract Infections: a Before-and-after Study to Assess Guidelines' Impact on Patients' Outcomes
The Committee of Infectiology of the French Association of Urology (CIAFU) provided, for the first time in 2020, comprehensive guidelines for ureteral stent-associated urinary tract infections (USAUTI) prevention, diagnosis and treatment. Since evidence lacked in terms of appropriate treatment, guidelines could not support systematic change of US in case of USAUTI.
This study aims to evaluate whether "after guidelines group" patients treated for USAUTI had different occurrence of at least one relapse or recurrence than "before guidelines group".
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Benjamin Lefevre, M.D. PhD
- Phone Number: +33383154097
- Email: b.lefevre@chru-nancy.fr
Study Contact Backup
- Name: Tahani Sara
- Phone Number: +33383154097
- Email: s.tahani@chru-nancy.fr
Study Locations
-
-
Lorraine
-
Nancy, Lorraine, France, 54000
- Recruiting
- Nancy University Hospital
-
Contact:
- Benjamin Lefevre, MD PhD
- Phone Number: +33383154097
- Email: b.lefevre@chru-nancy.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- All patients with indwelling ureteral catheter
- AND confirmed or probable urinary tract infection
Exclusion Criteria:
- Patient's opposition
- History of ileal conduit urinary diversion
- Second or more urinary tract infection during the study period
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Before guidelines
Patients treated for ureteral stent associated urinary tract infection in the University Hospital of Nancy from January 1, 2018 to May 31, 2020
|
|
|
After guidelines
Patients treated for ureteral stent associated urinary tract infection in the University Hospital of Nancy from August 1, 2020 to December 31, 2022
|
Guidelines promoting surgical abstention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Relapse OR recurrence of urinary tract infection
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Nephro-urologic complication
Time Frame: 1 year
|
Acute kidney injury ; hematuria ; pain ; stent migration or incrustation
|
1 year
|
|
Infectious complication
Time Frame: 1 year
|
Sepsis or septic shock
|
1 year
|
|
In-hospital and 1-year mortality
Time Frame: 1 year
|
all cause death
|
1 year
|
|
Resort to Watch or Reserve antibiotics
Time Frame: 1 year
|
antibiotics' WHO classifcation
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: +33383154097 Lefevre, M.D. PhD, Central Hospital, Nancy, France
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022PI037
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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