- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03928951
General Practitioner Reassessment of Urinary Infection Antibiotherapy Prescribed by Emergency Departments (ATB-IU)
General Practitioner Reassessment of the Antibiotherapy of Urinary Infections Initially Treated in Emergency Departments
Study Overview
Status
Conditions
Detailed Description
Urinary infections are at the origin of many emergency department consultations and antibiotic prescriptions. Increase of bacteria resistance to antibiotics is promoted by an inappropriate use of those antibiotics but initial prescription in emergency departments is complicated by brief clinical examinations, unavailable sampling results and risks of multi-resistant bacteria. Large diffusion of new recommendations for urinary infection management should improve the quality of initial antibiotic prescription. However emergency physicians have no knowledge of the reassessment of antibiotherapy 48 to 72 hours after initial prescription by general practitioners which is a quality criterion of good antibiotic use. The main purpose of this study is to estimate the reassessment rate by general practitioners of the urinary infection antibiotherapies prescribed in emergency departments.
Patients will be informed during their consultation in one of Toulon - La Seyne sur Mer hospital emergency departments. If they don't express opposition to their data collection, they will be included. A form will then be completed by emergency physicians with initial prescribed antibiotherapy, patients' general practitioners contact information and if patients have a shared medical file or not. 4 to 5 days later, patients' general practitioners will be contacted to know if urinary analysis results were transferred from emergency department to practitioners, if antibiotherapy was modified and if patients' shared medical file was consulted.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Var
-
Toulon, Var, France, 83056
- Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Every patient more than 18 years who was administered antibiotherapy for urinary infection in emergency department or for whom urinary infection was diagnosed in emergency department (cystitis, acute pyelonephritis, prostatitis)
Exclusion Criteria:
- Patients less than 18 years old
- Patients opposed to their data use
- Patients hospitalized more than 24 hours
- Patients taking antibiotherapy already before their arrival in emergency department
- Patients without sufficient reading capacities or understanding of french language to express opposition to their research participation
- Any other reason which, according to investigator, might interfere with research objective evaluation
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients suffering from urinary infection
Patients consulting in one of Toulon - La Seyne sur Mer hospital emergency departments because of urinary infection
|
Antibiotherapy will be prescribed by emergency physicians and general practitioners will be contacted 4 to 5 days later to know if antibiotherapy was modified
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of antibiotherapies modified by general practitioners
Time Frame: 6 months
|
Number of antibiotic prescriptions modified by general practitioners divided by the total number of initial antibiotic prescriptions
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of initial antibiotherapies not relevant to recommendations
Time Frame: 6 months
|
Number of initial antibiotic prescriptions not relevant to recommendations divided by the total number of initial antibiotic prescriptions
|
6 months
|
Rate of initial antibiotherapies not consistent with recommendations
Time Frame: 6 months
|
Number of initial antibiotic prescriptions not consistent (molecule, dose, period of time) with recommendations divided by the total number of initial antibiotic prescriptions
|
6 months
|
Rate of reassessments not relevant to recommendations
Time Frame: 6 months
|
Number of antibiotic prescription modifications not relevant to recommendations divided by the total number of antibiotic prescription modifications
|
6 months
|
Rate of reassessments not consistent with recommendations
Time Frame: 6 months
|
Number of antibiotic prescription modifications not consistent (molecule, dose, period of time) with recommendations divided by the total number of antibiotic prescription modifications
|
6 months
|
Frequence of use of shared medical file
Time Frame: 6 months
|
Number of patients for which the shared medical file is used divided by the total number of patients enrolled
|
6 months
|
Collaborators and Investigators
Investigators
- Study Director: Mouna EL OMRI, MD, Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
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
- 2019-CHITS-01
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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