Clinical Trials Directory

Trials / Completed

CompletedNCT04516187

Recognition of Serious Infections in the Elderly

Recognition of Serious Infections in the Elderly: Developing a Diagnostic Prediction Rule Based on Clinical Features and Blood Tests to Help Physicians Safely Rule Out a Serious Infection in an Older Patient Presenting to Ambulatory Care

Status
Completed
Phase
Study type
Observational
Enrollment
493 (actual)
Sponsor
KU Leuven · Academic / Other
Sex
All
Age
65 Years
Healthy volunteers
Not accepted

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).

Detailed 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.

Conditions

Interventions

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

Timeline

Start date
2020-10-16
Primary completion
2023-08-03
Completion
2023-08-03
First posted
2020-08-18
Last updated
2023-08-07

Locations

12 sites across 1 country: Belgium

Source: ClinicalTrials.gov record NCT04516187. Inclusion in this directory is not an endorsement.