NCT07559318

Brief Summary

Prospective, multicenter, non-interventional study conducted over 6 months, including patients presenting to the emergency department with suspected urinary tract infection managed as outpatients and discharged with or without empiric antibiotic therapy. Discharge antibiotic prescriptions are reviewed, with subsequent reassessment and optimization of treatment based on urine culture and susceptibility results

Trial Health

65
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Trial Health Score

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

Enrollment
330

participants targeted

Target at P75+ for all trials

Timeline
7mo left

Started Jun 2026

Shorter than P25 for all trials

Status
not yet recruiting

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 9, 2026

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 30, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

7 months

First QC Date

April 9, 2026

Last Update Submit

April 23, 2026

Conditions

Antimicrobial Stewarship in Emergency DepartmentOutpatient Urinary Infection

Keywords

Urinary tract infectionUrine culture and sensitivity testsAntimicrobial stewarshipSide effect and adverse event of antibioticsFluoroquinolones and 3rd-generation cephalosporins

Outcome Measures

Primary Outcomes (1)

  • Assess changes in fluoroquinolone and third-generation cephalosporin prescribing in outpatient urinary tract infections following adjustment based on urine culture and susceptibility results.

    At 48 hours - 72 hours after the patient inclusion

Secondary Outcomes (4)

  • Incidence (percentage) of adverse effects associated with antibiotics.

    At 1 month after the consultation in the Emergency department

  • Incidence (percentage) of antibiotic prescription savings in the Emergency department for outpatient urinary tract infections (cessation of prescription, shortening of treatment duration and/or narrowing of the spectrum) following the intervention

    At 48 hours - 72 hours after the patient inclusion

  • Assessment of patient satisfaction with medical follow-up via a question asked directly to the patient via a questionnaire (Better if more than 50 percent of patients are satisfied)

    At 1 month after the consultation in the Emergency department

  • Assessment of patients' knowledge of antibiotic resistance via a question asked directly to the patient via a questionnaire (Better if more than 50 percent of patients are satisfied)

    At 1 month after the consultation in the Emergency department

Study Arms (1)

Suspected of outpatient urinary tract infection

Inclusion of patients with outpatient urinary tract infection in emergency department

Other: Adaptation of antibiotics therapy for outpatient urinary infection following emergency care

Interventions

Adaptation of antibiotics therapy for outpatient urinary infection following emergency careOTHER

Re assessment of antibiotic therapy at 48 hours based on urine culture results : discontinuation or de-escalation to a narrower-spectrum agent

Suspected of outpatient urinary tract infection

Eligibility Criteria

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

Inclusion of patients presenting with suspected outpatient urinary tract infections, to the emergency department

You may qualify if:

  • Age 18 years or over
  • Patients presenting at emergency department, with symptoms suggestive of a urinary tract infection suitable for outpatient management (uncomplicated cystitis or cystitis at risk of complications, uncomplicated pyelonephritis or pyelonephritis at risk of complications, male urinary tract infection with or without fever) who have had a urine culture taken

You may not qualify if:

  • Refusal to participate in the study
  • Vulnerable person (person under guardianship or trusteeship, minor, person deprived of liberty, person unable to express their refusal)
  • Pregnant women
  • Severe urinary tract infection (sepsis, septic shock or requiring drainage, except for low urinary catheterisation)
  • Hospitalisation for a urinary tract infection or decompensation of another comorbidity
  • Suspected urinary tract infection without a urine culture having been performed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Anna BELKACEM, MD

CONTACT

01 43 86 21 62anna.belkacem@chiv.fr

Wissem TOUADI, Resident

CONTACT

wissemtouadi@gmail.com

Study Design

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

Study Record Dates

First Submitted

April 9, 2026

First Posted

April 30, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

April 30, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share