NCT07424989

Brief Summary

A urinary tract infection requires antibiotic treatment. While this treatment is intended to eliminate bacteria from the urine, it may also facilitate the development of resistant strains in the digestive tract. Patients are asked to provide stool samples on several occasions so that any potential side effects of this treatment on the digestive flora can be analysed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2021

Longer than P75 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

Study Start

First participant enrolled

July 4, 2021

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2025

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 13, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 20, 2026

Completed
Last Updated

February 24, 2026

Status Verified

February 1, 2026

Enrollment Period

3.9 years

First QC Date

February 13, 2026

Last Update Submit

February 20, 2026

Conditions

Keywords

systemic antibiotic therapyurinary tract infectionenteric carriage of EC3GRstools

Outcome Measures

Primary Outcomes (1)

  • Assessing the alteration of the gut microbiota induced by initial antibiotic therapy for urosepsis.

    Impact of initial antibiotic therapy on the increase in EC3GR enteric carriage defined as: * Positive EC3GR culture in stool sample 30-35 days after the end of antibiotic treatment (FT+30-35) in a patient with a negative (i.e. undetectable) EC3GR culture in stool sample on day 0 (D0) * Or a tenfold increase in the relative abundance of EC3GR between stool samples taken on D0 and FT-30-35 in patients with a positive EC3GR culture in stool samples taken on D0

    From enrollment to 30-35 days after the end of antibiotic treatment

Eligibility Criteria

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

Patients will be recruited via the Emergency Department (ED).

You may qualify if:

  • Adult patient requiring hospitalisation
  • Diagnosis of urinary tract infection requiring systemic antibiotic therapy with ceftriaxone, piperacillin/tazobactam or temocillin
  • Collection of a stool sample possible before or within 24 hours of starting systemic antibiotic therapy
  • Patient who has read and understood the information letter and given their consent to participate in the research

You may not qualify if:

  • Minor patient
  • Patient hospitalised in an intensive care unit
  • Digestive stoma
  • Patient not affiliated with social security
  • Pregnant woman, woman in labour or breastfeeding woman
  • Person deprived of liberty by administrative or judicial decision
  • Person placed under judicial protection, guardianship or curatorship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Rouen

Rouen, 76031, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

* Collection of stool samples using a sterile device that limits contamination * Collection of two stool samples using (i) a device that allows live bacteria to be stored at room temperature for up to 72 hours, (ii) a device that allows genetic material (DNA, RNA) to be stored for up to seven days.

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

First Submitted

February 13, 2026

First Posted

February 20, 2026

Study Start

July 4, 2021

Primary Completion

May 28, 2025

Study Completion

May 28, 2025

Last Updated

February 24, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations