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NCT Number: NCT05847036

Profiles of Urinary Tract Infections in General Practice

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cabinet de groupe

Saint-Maur-des-Fossés, Saint Maur, 94100, France

Location status: Recruiting

Location contact

Véronique Orcel, Dr

CONTACT

[email protected]

06.68.53.69.92

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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.

    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

  1. For general practioners' practices:

    Time frame: 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:

    Time frame: 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:

    Time frame: 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:

    Time frame: At Day 14 after the end of the treatment

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

Study contacts

Contact information is provided by the study sponsor or research team.

Emilie FERRAT, Dr

CONTACT

[email protected]

01 84 23 77 94

Véronique ORCEL, Dr

CONTACT

[email protected]

01 42 83 59 68

Sponsors and collaborators

Lead sponsor

CNGE Conseil

Other

Registry information

Official study title

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

Acronym: PODIUM

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 6, 2023
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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