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
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
|Study Type :||Observational|
|Actual Enrollment :||500 participants|
|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|
- Other: Diagnostic approaches
General practitioners will register the diagnostic process in patients with a suspected urinary tract infectionOther Name: Stix, microscopy, culture
- 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
- 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.
- Number of days until microbiological cure. [ Time Frame: 8 months ]Number of days until microbiological cure (i.e. culture reported as negative).
- Prevalence of resistant strains [ Time Frame: 8 months ]Sensibility test
Biospecimen Retention: Samples Without DNA
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
|Lægerne Simonsen og Grubbe|
|Copenhague, Denmark, 2300|
|Study Director:||Lars Bjerrum, Professor||Department of general practice, University of Copenhagen|