Profiles of Urinary Tract Infections in General Practice
NCT ID: NCT05847036
Last Updated: 2024-07-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
500 participants
OBSERVATIONAL
2023-12-15
2025-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Prevention of Cystitis.
NCT03744338
General Practitioner Reassessment of Urinary Infection Antibiotherapy Prescribed by Emergency Departments
NCT03928951
Epidemiology of Acute Bacterial Uncomplicated Cystitis in General Practice
NCT00958295
Safety and Efficacy of a Weekly Oral Cyclic Antibiotic Programme in the Prevention of Urinary Tract Infection on Neurological Bladder
NCT01388413
Identification of Predictive Blood Biomarkers of Recurrent Urinary Tract Infections
NCT03819712
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
CNGE Conseil
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Véronique ORCEL, Dr
Role: PRINCIPAL_INVESTIGATOR
Département Universitaire d'Enseignement et de Recherche de Médecine Générale de Créteil
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cabinet de groupe
Saint-Maur-des-Fossés, Saint Maur, France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Caron F, Galperine T, Flateau C, Azria R, Bonacorsi S, Bruyere F, Cariou G, Clouqueur E, Cohen R, Doco-Lecompte T, Elefant E, Faure K, Gauzit R, Gavazzi G, Lemaitre L, Raymond J, Senneville E, Sotto A, Subtil D, Trivalle C, Merens A, Etienne M. Practice guidelines for the management of adult community-acquired urinary tract infections. Med Mal Infect. 2018 Aug;48(5):327-358. doi: 10.1016/j.medmal.2018.03.005. Epub 2018 May 16. No abstract available.
Grigoryan L, Trautner BW, Gupta K. Diagnosis and management of urinary tract infections in the outpatient setting: a review. JAMA. 2014 Oct 22-29;312(16):1677-84. doi: 10.1001/jama.2014.12842.
Soudais B, Lacroix-Hugues V, Meunier F, Gillibert A, Darmon D, Schuers M. Diagnosis and management of male urinary tract infections: a need for new guidelines. Study from a French general practice electronic database. Fam Pract. 2021 Jul 28;38(4):432-440. doi: 10.1093/fampra/cmaa136.
Kinouani S, de Lary de Latour H, Joseph JP, Letrilliart L. Diagnostic strategies for urinary tract infections in French general practice. Med Mal Infect. 2017 Oct;47(6):401-408. doi: 10.1016/j.medmal.2017.05.003. Epub 2017 Jun 9.
Vincent YM, Frachon A, Buffeteau C, Conort G. Construction of a patient decision aid for the treatment of uncomplicated urinary tract infection in primary care. BMC Fam Pract. 2021 Jan 26;22(1):26. doi: 10.1186/s12875-021-01374-3.
Piraux A, Faure S, Naber KG, Alidjanov JF, Ramond-Roquin A. Changes in the management of urinary tract infections in women: impact of the new recommendations on antibiotic prescribing behavior in France, between 2014 and 2019. BMC Health Serv Res. 2021 Jun 28;21(1):612. doi: 10.1186/s12913-021-06653-4.
Lugtenberg M, Burgers JS, Zegers-van Schaick JM, Westert GP. Guidelines on uncomplicated urinary tract infections are difficult to follow: perceived barriers and suggested interventions. BMC Fam Pract. 2010 Jun 28;11:51. doi: 10.1186/1471-2296-11-51.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CNGE-2021-05
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.