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Completed

NCT Number: NCT04516187

Recognition of Serious Infections in the Elderly

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).

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Key information

Conditions

Infection Disease Infections Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

De Driehoek Paal, Paal, Limburg, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

signs and symptoms, blood tests

Diagnostic Test

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

Primary outcomes

  1. Diagnostic accuracy 1

    Time frame: 30 days

    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

Secondary outcomes

  1. Diagnostic accuracy 2

    Time frame: 30 days

    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

Other outcomes

  1. Net benefit: number of patients correctly classified as having a serious infection

    Time frame: 30 days

    To assess the added value of prediction model based decisions over treat all and treat none at clinically relevant thresholds

  2. Diagnostic accuracy 3

    Time frame: 30 days

    Sensitivity, specificity, positive and negative predictive value and likelihood ratios of tests across the most often occurring infection types

  3. Descriptive 1: Prevalence (%) of serious infections in the study population

    Time frame: 30 days

    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.

  4. Descriptive 2: multivariate analysis (no outcome)

    Time frame: 30 days

    To describe features independently associated with a physicians' gut feeling of serious infection in an older patient

  5. Diagnostic accuracy 4

    Time frame: 30 days

    Sensitivity and specificity of the developed prediction rules compared to existing prediction rules

  6. Diagnostic accuracy, sensitivity analysis

    Time frame: 30 days

    Sensitivity and specificity of the prediction rules taking all-cause mortality versus mortality due to infection as an outcome

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Registry information

Official study title

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

Acronym: ROSIE

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Aug 18, 2020
Registry last updated
Aug 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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