Does the National Health Insurance Card Allow us to Predi... | NCT02292160

Studies
Does the National Health Insurance Card Allow us to Predict Antibiotic Resistance?

NCT02292160

Sponsor

University Hospital, Rouen

Status

Completed

Last Update Posted

Apr 16, 2026Actual

Enrollment

1,128Actual

Phase

Not provided

Conditions

Urinary Tract Infection Empiric Antibiotic

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2015

Primary Completion Date

Feb 2017Actual

Completion Date

Feb 2017Actual

First Submitted Date

Oct 20, 2014

First Submission Date that Met QC Criteria

Nov 12, 2014

First Posted Date

Nov 17, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 13, 2026

Last Update Posted Date

Apr 16, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 simplified

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,128Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Frequency of antibiotic resistant organisms	Frequency of antibiotic resistant organisms in patient with urinary infection	One year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

national health insurance card available
community acquired urinary tract infection

Exclusion Criteria:

incapacity to accept an inform consent
hospitalized acquired urinary tract infection
national health insurance card non available

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patient with an community-acquired urinary tract infection

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Francois CARON, Pr	UH Rouen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Lbmr de Normandie		Elbeuf			France
Rouen University Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29635629	Result	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.
38936476