Profiles of Urinary Tract Infections in General Practice

NCT05847036 | Recruiting

• 1 other identifier: CNGE-2021-05
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Tract Infections

Outcome Measures

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.

  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 Outcomes (4)

• 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 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

• For short-term evolutionary trajectories:

  At Day 14 after the end of the treatment

• For the factors associated with the prescription of antibiotics:

  At Day 14 after the end of the treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients consulting in general practice for suspected urinary tract infection

You may qualify if:

• 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

Sponsors & Collaborators

• CNGE Conseil: lead

Study Sites (1)

Cabinet de groupe

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

RECRUITING

Related Publications (7)

• 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.

  PMID: 29759852 BACKGROUND

• 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.

  PMID: 25335150 BACKGROUND

• 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.

  PMID: 33340317 BACKGROUND

• 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.

  PMID: 28606664 BACKGROUND

• 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.

  PMID: 33499824 BACKGROUND

• 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.

  PMID: 34182991 BACKGROUND

• 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.

  PMID: 20584276 BACKGROUND

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Véronique ORCEL, Dr

  Département Universitaire d'Enseignement et de Recherche de Médecine Générale de Créteil

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Véronique ORCEL, Dr

CONTACT

01 42 83 59 68; veronique.orcel@laposte.net

Emilie FERRAT, Dr

CONTACT

01 84 23 77 94; emilie.ferrat@u-pec.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2023
• First Posted: May 6, 2023
• Study Start: December 15, 2023
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: July 3, 2024

Record last verified: 2024-07

Locations

FR (1)