Urinary Tract InfectionsIUR63NCT04361864
Cross-sectional Survey on Patients With Urinary Tract Infections in Puy-de-Dôme : Epidemiology of Recurrent Urinary Tract Infections and Risk Factors
An observational study of Urinary Tract Infections, run by University Hospital, Clermont-Ferrand at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Tract Infections
- How many people
- 561 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jan 2021to 2 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with at least one urinary tract infection during year 2019
Who may be able to join
- 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)
Who cannot join
- pregnancy during year 2019
- none urinary tract infection reported in 2019
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Urinary Tract Infections
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| RUTI | patients with at least 3 episodes of UTI during 2019 | |
| UTI | patients with one or two episodes of UTI during 2019 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: During year 2019
Secondary outcomes (9)
age in year
Risk factors of recurrent urinary tract infections
Measured: day 1
sexe
Risk factors of recurrent urinary tract infections
Measured: day 1
, medical and surgical history
Risk factors of recurrent urinary tract infections
Measured: day 1
life habits
Risk factors of recurrent urinary tract infections
Measured: day 1
number of visits at the general practitioner
measure of healthcare consumption with the number of visits at the general practitioner performed
Measured: during year 2019
number of urinalysis
measure of healthcare consumption with the number of urinalysis performed
Measured: during year 2019
number of antibiotic therapies
measure of healthcare consumption with the number of antibiotic therapies performed
Measured: during year 2019
quality of life
quality of life evaluated with a self-reported questionnaire inspired by the Leicester Impact Scale
Measured: during year 2019
bacteriological characteristics of recurrent urinary tract infections
evaluated with results of urinalysis, bacterial identification and antimicrobial susceptibility
Measured: during year 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start15 Jan 2021
- Primary completion1 Feb 2021
- Study completion2 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 561 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Caisse Primaire d'Assurance Maladie du Puy-de-Dôme
- Responsible party
- Sponsor
- Investigators
- Olivier Lesens, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04361864
- Sponsor's protocol ID
- RNI 2019 LESENS
- Other IDs
- 2019-A02703-54
- Acronym
- IUR63
- Status last verified
- May 2021
- First submitted
- 22 Apr 2020
- Last updated
- 7 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-sectional Survey on Patients With Urinary Tract Infections in Puy-de-Dôme : Epidemiology of Recurrent Urinary Tract Infections and Risk Factors
- ClinicalTrials.gov ID
- NCT04361864
- Acronym / sponsor ID
- IUR63 / RNI 2019 LESENS
- Conditions
- Urinary Tract Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 561 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Caisse Primaire d'Assurance Maladie du Puy-de-Dôme
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 2 Feb 2021 (actual)
- First posted
- 24 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RUTI | – | –patients with at least 3 episodes of UTI during 2019 |
| UTI | – | –patients with one or two episodes of UTI during 2019 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with at least one urinary tract infection during year 2019
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (2 listed)
- pregnancy during year 2019
- none urinary tract infection reported in 2019
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of recurrent urinary tract infections
Time frame: During year 2019
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
9 secondary outcomes
age in year
Time frame: day 1
sexe
Time frame: day 1
, medical and surgical history
Time frame: day 1
life habits
Time frame: day 1
number of visits at the general practitioner
Time frame: during year 2019
number of urinalysis
Time frame: during year 2019
number of antibiotic therapies
Time frame: during year 2019
quality of life
Time frame: during year 2019
bacteriological characteristics of recurrent urinary tract infections
Time frame: during year 2019
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier Lesens principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Tract Infections, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of recurrent urinary tract infections (time frame: During year 2019). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2021.