NCT04361864

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
561

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 24, 2020

Completed
9 months until next milestone

Study Start

First participant enrolled

January 15, 2021

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2021

Completed
Last Updated

May 7, 2021

Status Verified

May 1, 2021

Enrollment Period

17 days

First QC Date

April 22, 2020

Last Update Submit

May 6, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • age in year

    day 1

  • sexe

    day 1

  • , medical and surgical history

    day 1

  • life habits

    day 1

  • number of visits at the general practitioner

    during year 2019

  • +4 more secondary outcomes

Study Arms (2)

RUTI

patients with at least 3 episodes of UTI during 2019

UTI

patients with one or two episodes of UTI during 2019

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults with at least one urinary tract infection during year 2019

You may qualify if:

  • 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)

You may not qualify if:

  • pregnancy during year 2019
  • none urinary tract infection reported in 2019

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Clermont Ferrand

Clermont-Ferrand, 63003, France

Location

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Olivier Lesens

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2020

First Posted

April 24, 2020

Study Start

January 15, 2021

Primary Completion

February 1, 2021

Study Completion

February 2, 2021

Last Updated

May 7, 2021

Record last verified: 2021-05

Locations