Diagnostic Tools in Patients With a Suspected Urinary Tract Infection in Primary Care

NCT02249273 | Completed

• 1 other identifier: UC-CARE-001
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Inappropriate use of antibiotics is one of the main causes for the increase of antibiotic resistance strains. In Denmark general practice accounts for 90% of all prescribed antibiotics and one of the most common reasons for prescribing antibiotics is the suspicion of a urinary tract infection (UTI). The use of point-of-care test is meant to decrease the uncertainty about the bacterial origin of the symptoms; however, there is a paucity of knowledge about the validity of the different diagnostic approaches, thus impacting on the proper use of antibiotics. Objective: To assess the diagnostic validity of different diagnostic approaches in patients with a suspected urinary tract infection and assess the impact on appropriate use of antibiotics. Methods: 70 practices at the capital region will consecutively include 15-20 patients. The inclusion criteria of the patients comprise: a) Suspected Urinary tract infection, b) \> 18 years of age, c) patient consulting during office hours. Data at patient and GP level will be gathered. 16 diagnostic approaches will be compared and proper use of antibiotics will be assessed as a two-step process. The first step is the decision made during the consultation and the second step is the decision made after the consultation. Sensitivity, specificity and predictive values will be measure for each diagnostic approach using urine culture as a gold standard. The impact on proper use of antibiotics will be assessed in a hierarchical multivariable logistic model.

Conditions

Urinary Tract Infections

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with appropriate antibiotic treatment decisions for each diagnostic approach during the consultation.

  We will compare appropriate use of antibiotics within the different diagnostic approaches

  8 months

Secondary Outcomes (3)

• Number of days until clinical cure.

  8 months

• Number of days until microbiological cure.

  8 months

• Prevalence of resistant strains

  8 months

Interventions

Diagnostic approaches OTHER

General practitioners will register the diagnostic process in patients with a suspected urinary tract infection

Also known as: Stix, microscopy, culture

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

Patients \>0 18 years old attending primary care services during offcie hours with a suspected urinary tract infection

You may qualify if:

• Suspected Urinary tract infection
• \> 18 years of age
• Patient consulting during office hours.

You may not qualify if:

• Patients currently taking antibiotics
• Inability to complete a diary and send two urine samples during the time of the study
• Patients with a urinary catheter as they have a closer follow-up between first and secondary care.

Sponsors & Collaborators

• University of Copenhagen: lead

Study Sites (1)

Lægerne Simonsen og Grubbe

Copenhagen, 2300, Denmark

Location

Related Publications (3)

• Cordoba G, Holm A, Sorensen TM, Siersma V, Sandholdt H, Makela M, Frimodt-Moller N, Bjerrum L. Use of diagnostic tests and the appropriateness of the treatment decision in patients with suspected urinary tract infection in primary care in Denmark - observational study. BMC Fam Pract. 2018 May 16;19(1):65. doi: 10.1186/s12875-018-0754-1.

  PMID: 29769025 DERIVED

• Cordoba G, Holm A, Hansen F, Hammerum AM, Bjerrum L. Prevalence of antimicrobial resistant Escherichia coli from patients with suspected urinary tract infection in primary care, Denmark. BMC Infect Dis. 2017 Oct 10;17(1):670. doi: 10.1186/s12879-017-2785-y.

  PMID: 29017466 DERIVED

• Cordoba G, Sorensen TM, Holm A, Bjornvad CR, Bjerrum L, Jessen LR. Exploring the feasibility and synergistic value of the One Health approach in clinical research: protocol for a prospective observational study of diagnostic pathways in human and canine patients with suspected urinary tract infection. Pilot Feasibility Stud. 2015 Nov 10;1:38. doi: 10.1186/s40814-015-0036-9. eCollection 2015.

  PMID: 27965816 DERIVED

Related Links

• University of Copenhagen research center for control of antibiotic resistance

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine sample

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

Microscopy; Culture Techniques

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; In Vitro Techniques

Study Officials

• Lars Bjerrum, Professor

  Department of general practice, University of Copenhagen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD-MPH

Study Record Dates

• First Submitted: September 22, 2014
• First Posted: September 25, 2014
• Study Start: December 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: October 9, 2017

Record last verified: 2017-10

Locations

DK (1)