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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04361864
Other study ID # RNI 2019 LESENS
Secondary ID 2019-A02703-54
Status Completed
Phase
First received
Last updated
Start date January 15, 2021
Est. completion date February 2, 2021

Study information

Verified date May 2021
Source University Hospital, Clermont-Ferrand
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Urinary tract infections (UTI) are an important part of infectious diseases. For some patients, those infections are recurrent and have many consequences such as altered quality of life, recurrent symptoms, antibiotics overuse… The primary purpose of this study is to estimate the proportion of patients in Puy-de-Dôme with recurrent urinary tract infections among patients with at least one UTI during 2019. The secondary purposes are : characteristics of patients with recurrent UTI, by sex ; determine predictive factors of recurrent UTI, by sex ; describe bacterial ecology of recurrent UTI and the proportion of multi-resistant bacteria.


Recruitment information / eligibility

Status Completed
Enrollment 561
Est. completion date February 2, 2021
Est. primary completion date February 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - patient from 18 years old - affiliated to the french healthcare system - with at least one urinary tract infection during year 2019 - has accepted email contact with CPAM 63 (Caisse Primaire d'Assurance Maladie du Puy-de-Dôme) Exclusion Criteria: - pregnancy during year 2019 - none urinary tract infection reported in 2019

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Chu Clermont Ferrand Clermont-Ferrand

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Clermont-Ferrand Caisse Primaire d'Assurance Maladie du Puy-de-Dôme

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of recurrent urinary tract infections Proportion, with its 95% confidence interval, of recurrent urinary tract infections, by sex, in the population of Puy-de-Dôme who reported having had at least one urinary tract infection in the year 2019.
The diagnosis of recurrent urinary tract infection will be at least 3 urinary tract infections in one year
During year 2019
Secondary age in year Risk factors of recurrent urinary tract infections day 1
Secondary sexe Risk factors of recurrent urinary tract infections day 1
Secondary , medical and surgical history Risk factors of recurrent urinary tract infections day 1
Secondary life habits Risk factors of recurrent urinary tract infections day 1
Secondary number of visits at the general practitioner measure of healthcare consumption with the number of visits at the general practitioner performed during year 2019
Secondary number of urinalysis measure of healthcare consumption with the number of urinalysis performed during year 2019
Secondary number of antibiotic therapies measure of healthcare consumption with the number of antibiotic therapies performed during year 2019
Secondary quality of life quality of life evaluated with a self-reported questionnaire inspired by the Leicester Impact Scale during year 2019
Secondary bacteriological characteristics of recurrent urinary tract infections evaluated with results of urinalysis, bacterial identification and antimicrobial susceptibility during year 2019
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