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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04516187
Other study ID # S63771
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 16, 2020
Est. completion date August 3, 2023

Study information

Verified date August 2023
Source KU Leuven
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this diagnostic accuracy study is to develop a clinical prediction rule based on signs, symptoms, patient characteristics and blood tests, to be used in ambulatory care to help physicians safely rule out a serious infection in an older patient. It will be performed in general practices and emergency care departments across Flanders (Belgium).


Description:

This is a cross-sectional diagnostic cohort study in older adults presenting to ambulatory care, including a follow-up period of 30 days. This study will be used to construct an algorithm consisting of clinical features and blood test results to identify serious infections. The study will run in ambulatory care in Flanders. Recruitment is expected to last 2.5 years, with each patient entering the study only once. Older adults will be approached for possible participation in the study by practice staff. There is only one study visit. Those who agree to participate via written informed consent will have demographics and clinical features recorded. A blood sample will be taken in all participants on study entry. Follow-up information for all participants will be collected using electronic medical record notes (EMD) and patient diaries. Treatment and other management decisions will be left to the treating physicians' discretion.


Recruitment information / eligibility

Status Completed
Enrollment 493
Est. completion date August 3, 2023
Est. primary completion date August 3, 2023
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - Aged 65 years or older - Presenting to a general practice with an acute illness with a maximum duration of 10 days since onset - Suspicion of infectious disease (this may include suspicion of an acute exacerbation of COPD) - Patient or proxy of the patient is willing and able to give informed consent for participation. Exclusion Criteria: The participant may not enter the study if any of the following apply: - Too clinically unstable to waste time on study procedures - Indwelling catheter in situ - Immunocompromised or currently receiving medication for systemic immune-suppression, including corticosteroids - Being admitted to hospital for longer than 24 hours less than 7 days before study entry, or having undergone surgery in the previous 30 days - Living in a nursing home (both short term and long term stay) (only in general practice cohort) - Patient was already included in the study

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
signs and symptoms, blood tests
signs and symptoms as observed by the treating physician + blood tests (CRP, Procalcitonin, White blood cell count)

Locations

Country Name City State
Belgium De Wijkpraktijk Antwerp
Belgium De Leeuwenkaart Brasschaat
Belgium Huisartsenpraktijk Arcade Gelrode
Belgium De Bilter 28 Heers
Belgium Emergency Department Heilig Hart hospital Leuven Leuven
Belgium Emergency Department University Hospitals Leuven Leuven
Belgium Emergency Department St.-Jozef Hospital Malle Malle
Belgium DRLA Mortsel
Belgium De Driehoek Paal Paal
Belgium De Driehoek Paal Paal Limburg
Belgium Huisartspraktijk Brustempoort Sint-Truiden
Belgium Onspraktijk Wilrijk

Sponsors (1)

Lead Sponsor Collaborator
KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Other Net benefit: number of patients correctly classified as having a serious infection To assess the added value of prediction model based decisions over treat all and treat none at clinically relevant thresholds 30 days
Other Diagnostic accuracy 3 Sensitivity, specificity, positive and negative predictive value and likelihood ratios of tests across the most often occurring infection types 30 days
Other Descriptive 1: Prevalence (%) of serious infections in the study population To investigate the potential for incorporation bias (diagnostic review bias) when establishing the reference standard in an expert review panel, with and without information on biomarker results. 30 days
Other Descriptive 2: multivariate analysis (no outcome) To describe features independently associated with a physicians' gut feeling of serious infection in an older patient 30 days
Other Diagnostic accuracy 4 Sensitivity and specificity of the developed prediction rules compared to existing prediction rules 30 days
Other Diagnostic accuracy, sensitivity analysis Sensitivity and specificity of the prediction rules taking all-cause mortality versus mortality due to infection as an outcome 30 days
Primary Diagnostic accuracy 1 Sensitivity and specificity of clinical prediction rules that are based on signs, symptoms, patient characteristics with and without blood tests, to be used in ambulatory care to help physicians safely rule out a serious infection in an older patient 30 days
Secondary Diagnostic accuracy 2 Sensitivity, specificity, positive and negative predictive value and likelihood ratios of individual signs, symptoms, patient characteristics and blood tests for diagnosing a serious infection in persons aged =65 years 30 days
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