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Clinical Trials/NCT05847036
NCT05847036
Recruiting
Not Applicable

Profiles of Urinary Tract Infections in General Practice : a Prospective Multicentre Cohort Study

CNGE Conseil1 site in 1 country500 target enrollmentDecember 15, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Urinary Tract Infections
Sponsor
CNGE Conseil
Enrollment
500
Locations
1
Primary Endpoint
The primary outcome will be the number of homogeneous profiles of patients with UTI in general practice and their characteristics using clinico-bacteriological indicators.
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

Urinary tract infections (UTIs) are one of the most common bacterial infections managed in general practice: they are the 2nd site of community-acquired bacterial infection after respiratory infections (4-6 million consultations per year in France).

UTIs represent 15% of total antibiotic prescriptions in France. Antibiotics recommended for UTIs, except for cystitis, are considered as "critical" (highly generating bacterial resistances). UTIs are a potential source of antibiotic resistance: often inappropriate antibiotic prescriptions, evolution of the resistance profiles of the bacteria involved, emergence of multi-resistant strains.

The first hypothesis is that there are other profiles of clinical UTI situations in general practice than typical cystitis or pyelonephritis, including intermediate forms.

The second hypothesis is that these intermediate forms of UTI are subject to longer durations of antibiotherapy, and that probable explanatory factors need to be identified.

Detailed Description

Urinary tract infections (UTIs) are one of the most common bacterial infections managed in general practice: they are the 2nd site of community-acquired bacterial infection after respiratory infections (4-6 million consultations per year in France). UTIs represent 15% of total antibiotic prescriptions in France. Antibiotics recommended for UTIs, except for cystitis, are considered as "critical" (highly generating bacterial resistances). UTIs are a potential source of antibiotic resistance: often inappropriate antibiotic prescriptions, evolution of the resistance profiles of the bacteria involved, emergence of multi-resistant strains. Current guidelines classify UTIs as "uncomplicated UTI" (cystitis and pyelonephritis) and "UTI at risk of complication" (cystitis, pyelonephritis and male UTI) \[1-2\]. However, in primary care, pathologies are diagnosed at an early stage: the clinical signs usually described by scientific societies are not always all found, and the descriptions are not always adapted to the realities encountered in general practice \[3-6\]. Some clinical situations do not fit into the systematic categories of the guidelines, with "intermediate" forms (such as pain in the lumbar fossae without fever "cysphritis" or other atypical presentations) \[3\]. The current literature in general practice highlights these issues: the need for prospective cohorts in real-life practice to identify these profiles and develop more appropriate guidelines \[3-6\]. Treatment for these intermediate forms is not obvious and is often empirical: potentially longer antibiotherapies, with possible worsening of antibiotic resistance \[7\]. The first hypothesis is that there are other profiles of clinical UTI situations in general practice than typical cystitis or pyelonephritis, including intermediate forms. The second hypothesis is that these intermediate forms of UTI are subject to longer durations of antibiotherapy, and that probable explanatory factors need to be identified.

Registry
clinicaltrials.gov
Start Date
December 15, 2023
End Date
January 31, 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
CNGE Conseil
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patient ≥18 years old
  • Patient presenting one or more of the following clinical signs suggestive of urinary tract infection in general practice consultation:
  • fever (temperature \> 38°C)
  • chills, sweats
  • burning urination
  • urinary urgency
  • pollakiuria
  • lumbar and/or pelvic pain
  • abnormal urine appearance: cloudy, malodorous, macroscopic haematuria
  • absence of leucorrhoea

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

The primary outcome will be the number of homogeneous profiles of patients with UTI in general practice and their characteristics using clinico-bacteriological indicators.

Time Frame: At Day 14 after the end of the Antiobiotic treatment

The primary outcome will be the rate and the clinical-bacteriological characteristics of the identified profiles of patients with UTI in general practice

Secondary Outcomes

  • For general practioners' practices:(At Day 0, at Day 14 after the end of the treatment and between Day 0 and Day14 after the end of the treatment)
  • For the factors associated with the prescription of antibiotics:(At Day 14 after the end of the treatment)
  • For short-term evolutionary trajectories:(At Day 14 after the end of the treatment)

Study Sites (1)

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