Profiles of Urinary Tract Infections in General Practice

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Urinary Tract Infections

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome will be the number of homogeneous profiles of patients with UTI in general practice and their characteristics using clinico-bacteriological indicators. | The primary outcome will be the rate and the clinical-bacteriological characteristics of the identified profiles of patients with UTI in general practice | At Day 14 after the end of the Antiobiotic treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| For general practioners' practices: | 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 | 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 short-term evolutionary trajectories: | Number of consultations (in general practice or other specialty) and reasons Number of emergency department visits Number of unscheduled hospitalizations related to UTI | 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 | 
| For short-term evolutionary trajectories: | 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) | At Day 14 after the end of the treatment | 
| For the factors associated with the prescription of antibiotics: | Percentage of antibiotics prescribed, Choice of antibiotic class, whether 'delayed' or immediate, duration, posology | At Day 14 after the end of the treatment |