Recognition of Serious Infections in the Elderly

KU Leuven493 enrolled

Overview

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).

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.

Study Type

OBSERVATIONAL

Enrollment

493

Conditions

Infection

Interventions

signs and symptoms, blood testsDIAGNOSTIC_TEST

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

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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

Locations (12)

De Driehoek Paal

Paal, Limburg, Belgium

De Wijkpraktijk

Antwerp, Belgium

De Leeuwenkaart

Brasschaat, Belgium

Huisartsenpraktijk Arcade

Outcomes

Primary Outcomes

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

Time frame: 30 days

Secondary Outcomes

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

Time frame: 30 days

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.