Urinary Tract Infection Empiric AntibioticNCT02292160
Does the National Health Insurance Card Allow us to Predict Antibiotic Resistance?
An observational study of Urinary Tract Infection Empiric Antibiotic, run by University Hospital, Rouen at 2 sites in France.
Trial summary
The objective is to determine if data from the National Insurance Health card (giving antibiotics and hospitalizations in the past 18 months) allow to predict the individual risk of antibiotic resistance and to identify population groups for which probabilistic antibiotics regimen of urinary tract infection could be… Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Urinary Tract Infection Empiric Antibiotic
- How many people
- 1,128 participants
- Where
- 2 sitesFrance
- Study dates
- Sep 2015to Feb 2017
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patient with an community-acquired urinary tract infection
Who may be able to join
- national health insurance card available
- community acquired urinary tract infection
Who cannot join
- incapacity to accept an inform consent
- hospitalized acquired urinary tract infection
- national health insurance card non available
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Does the National Health Insurance Card Allow us to Predict Antibiotic Resistance? Pilot Study to Guide Probabilistic Antibiotic Regimens of Community-acquired Urinary Tract Infections
The objective is to determine if data from the National Insurance Health card (giving antibiotics and hospitalizations in the past 18 months) allow to predict the individual risk of antibiotic resistance and to identify population groups for which probabilistic antibiotics regimen of urinary tract infection could be simplified
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of antibiotic resistant organisms
Frequency of antibiotic resistant organisms in patient with urinary infection
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2014 (estimated)
- Study startSep 2015
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Urinary Tract Infection Empiric AntibioticStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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
- Prospective
- Enrolment
- 1,128 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francois CARON, Pr, Principal investigator, UH Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02292160
- Sponsor's protocol ID
- 2013/186/HP
- Status last verified
- Apr 2026
- First submitted
- 20 Oct 2014
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Alexandre K, Reveillon-Istin M, Fabre R, Delbos V, Etienne M, Pestel-Caron M, Dahyot S, Caron F. Temocillin against Enterobacteriaceae isolates from community-acquired urinary tract infections: low rate of resistance and good accuracy of routine susceptibility testing methods. J Antimicrob Chemother. 2018 Jul 1;73(7):1848-1853. doi: 10.1093/jac/dky101.
PubMed 29635629Alexandre K, Gillibert A, Dahyot S, Fabre R, Kuhn F, Benichou J, Delbos V, Caron F. Individual health insurance data of antibiotic delivery in previous months as a tool to predict bacterial resistance of urinary tract infection: A prospective cohort study. Infect Dis Now. 2024 Sep;54(6):104942. doi: 10.1016/j.idnow.2024.104942. Epub 2024 Jun 25.
PubMed 38936476Vautrin N, Dahyot S, Leoz M, Caron F, Grand M, Feldmann A, Gravey F, Legris S, Ribet D, Alexandre K, Pestel-Caron M. Are Escherichia coli causing recurrent cystitis just ordinary uropathogenic E. coli (UPEC) strains? Virulence. 2025 Dec;16(1):2444689. doi: 10.1080/21505594.2024.2444689. Epub 2024 Dec 26.
PubMed 39726097
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the National Health Insurance Card Allow us to Predict Antibiotic Resistance? Pilot Study to Guide Probabilistic Antibiotic Regimens of Community-acquired Urinary Tract Infections
- ClinicalTrials.gov ID
- NCT02292160
- Acronym / sponsor ID
- 2013/186/HP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,128 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 17 Nov 2014 (estimated)
- 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.
The objective is to determine if data from the National Insurance Health card (giving antibiotics and hospitalizations in the past 18 months) allow to predict the individual risk of antibiotic resistance and to identify population groups for which probabilistic antibiotics regimen of urinary tract infection could be simplified
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient with an community-acquired urinary tract infection
Key inclusion criteria (2 listed)
- national health insurance card available
- community acquired urinary tract infection
Key exclusion criteria (3 listed)
- incapacity to accept an inform consent
- hospitalized acquired urinary tract infection
- national health insurance card non available
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
Frequency of antibiotic resistant organisms
Time frame: One year
Frequency of antibiotic resistant organisms in patient with urinary infection
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 16 Apr 2026.
- Results publication: PubMed 29635629Alexandre K, Reveillon-Istin M, Fabre R, Delbos V, Etienne M, Pestel-Caron M, Dahyot S, Caron F. Temocillin against Enterobacteriaceae isolates from community-acquired urinary tract infections: low rate of resistance and good accuracy of routine susceptibility testing methods. J Antimicrob Chemother. 2018 Jul 1;73(7):1848-1853. doi: 10.1093/jac/dky101.
- Results publication: PubMed 38936476Alexandre K, Gillibert A, Dahyot S, Fabre R, Kuhn F, Benichou J, Delbos V, Caron F. Individual health insurance data of antibiotic delivery in previous months as a tool to predict bacterial resistance of urinary tract infection: A prospective cohort study. Infect Dis Now. 2024 Sep;54(6):104942. doi: 10.1016/j.idnow.2024.104942. Epub 2024 Jun 25.
- Results publication: PubMed 39726097Vautrin N, Dahyot S, Leoz M, Caron F, Grand M, Feldmann A, Gravey F, Legris S, Ribet D, Alexandre K, Pestel-Caron M. Are Escherichia coli causing recurrent cystitis just ordinary uropathogenic E. coli (UPEC) strains? Virulence. 2025 Dec;16(1):2444689. doi: 10.1080/21505594.2024.2444689. Epub 2024 Dec 26.
Related trials for Urinary Tract Infection Empiric Antibiotic
Not yet recruiting
Clinical Impact of a Machine Learning Decision Support System for Empirical Antibiotic Therapy
Pneumonia - Bacterial, Urinary Tract Infection Bacterial
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.
Francois CARON, Pr principal investigator
UH Rouen
2 sites 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 Infection Empiric Antibiotic, run by University Hospital, Rouen at 2 sites 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 2 inclusion and 3 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 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Frequency of antibiotic resistant organisms (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02292160, which also lists 3 linked publications.
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 16 Apr 2026.