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

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ClinicalTrials.gov Identifier: NCT02249273
Recruitment Status : Completed
First Posted : September 25, 2014
Last Update Posted : October 9, 2017
Sponsor:
Information provided by (Responsible Party):
Gloria Cristina Cordoba, University of Copenhagen

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.


Condition or disease Intervention/treatment
Urinary Tract Infections Other: Diagnostic approaches

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Diagnostic Process in Patients With a Suspected Urinary Trcat Infection in Danish Primary Care: Impact on Appropriate Use of Antibiotics and Patient's Recovery.
Study Start Date : December 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Diagnostic approaches
    General practitioners will register the diagnostic process in patients with a suspected urinary tract infection
    Other Name: Stix, microscopy, culture


Primary Outcome Measures :
  1. Percentage of patients with appropriate antibiotic treatment decisions for each diagnostic approach during the consultation. [ Time Frame: 8 months ]
    We will compare appropriate use of antibiotics within the different diagnostic approaches


Secondary Outcome Measures :
  1. Number of days until clinical cure. [ Time Frame: 8 months ]
    Number of days until clinical cure (i.e. first day without urinary symptoms)and number of days to become symptoms free.

  2. Number of days until microbiological cure. [ Time Frame: 8 months ]
    Number of days until microbiological cure (i.e. culture reported as negative).

  3. Prevalence of resistant strains [ Time Frame: 8 months ]
    Sensibility test


Biospecimen Retention:   Samples Without DNA
Urine sample


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02249273


Locations
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Denmark
Lægerne Simonsen og Grubbe
Copenhague, Denmark, 2300
Sponsors and Collaborators
University of Copenhagen
Investigators
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Study Director: Lars Bjerrum, Professor Department of general practice, University of Copenhagen

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gloria Cristina Cordoba, MD-MPH, University of Copenhagen
ClinicalTrials.gov Identifier: NCT02249273     History of Changes
Other Study ID Numbers: UC-CARE-001
First Posted: September 25, 2014    Key Record Dates
Last Update Posted: October 9, 2017
Last Verified: October 2017
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Urinary Tract Infections
Urologic Diseases