PODIUM: Profiles of Urinary Tract Infections in General Practice

Sponsor
CNGE Conseil (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05847036
Collaborator
(none)
500
14

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Profiles of Urinary Tract Infections in General Practice : a Prospective Multicentre Cohort Study
    Anticipated Study Start Date :
    Jun 1, 2023
    Anticipated Primary Completion Date :
    Jul 15, 2023
    Anticipated Study Completion Date :
    Jul 30, 2024

    Outcome Measures

    Primary Outcome Measures

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

    1. 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]

      Percentage of cytobacteriological examination of urine (CBEUs) prescribed Number and type of additional examinations prescribed Percentage of antibiotics prescribed, therapeutic class chosen, duration (in ordinal categories), posology

    2. For short-term evolutionary trajectories: [At Day 0, at Day 14 after the end of the treatment and between Day 0 and Day 14 after the end of the treatment]

      Number of consultations (in general practice or other specialty) and reasons Number of emergency department visits Number of unscheduled hospitalizations related to UTI

    3. For short-term evolutionary trajectories: [At Day 14 after the end of the treatment]

      Percentage of patients with worsening, stability or recovery of their symptoms as final condition (based on clinical assessment by GPs during a consultation at day 14)

    4. For the factors associated with the prescription of antibiotics: [At Day 14 after the end of the treatment]

      Percentage of antibiotics prescribed, Choice of antibiotic class, whether 'delayed' or immediate, duration, posology

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    • dysuria

    • lumbar and/or pelvic pain

    • abnormal urine appearance: cloudy, malodorous, macroscopic haematuria

    • absence of leucorrhoea

    • specifically in people > 70 years old:

    • recent onset urinary incontinence

    • sudden confusion

    • bladder globe

    • Positive urine dipstick and/or positive Cytobacteriological Examination of Urine (CBEU)

    • Patient affiliated with the French National Health Insurance or beneficiary of such a scheme.

    • Patient's oral non-opposition of participation in the study after receiving complete information about the protocol

    Non-inclusion Criteria:
    • Patient < 18 years old

    • Declared pregnancy

    • Patient with indwelling urinary catheter

    • Patient with functional or organic abnormality of the urinary tract

    • Patient with known severe immunodeficiency (HIV+ with CD4 count < 200/mm3, organ transplant, bone marrow transplant, patient on immunosuppressants, cirrhosis)

    • Patient with known severe chronic renal failure (clearance < 30 mL/min)

    • Patient previously treated with an antibiotic (for an other reason than a urinary tract infection and/or treatment failure of the urinary tract infection) in the past month before the inclusion consultation

    • Patient speaking little or no French

    • Patient with severe cognitive impairment

    • Patient with life expectancy < 3 months

    • Patient under legal protection, inability to give an oral non-opposition

    • Patient with severity criteria justifying hospitalization

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • CNGE Conseil

    Investigators

    • Principal Investigator: Véronique ORCEL, Dr, Département Universitaire d'Enseignement et de Recherche de Médecine Générale de Créteil

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Véronique ORCEL, Principal investigator, CNGE Conseil
    ClinicalTrials.gov Identifier:
    NCT05847036
    Other Study ID Numbers:
    • CNGE-2021-05
    First Posted:
    May 6, 2023
    Last Update Posted:
    May 6, 2023
    Last Verified:
    Apr 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 6, 2023