Recognition of Serious Infections in the Elderly

Infection Clinical Trial

— ROSIE  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04516187
• Other study ID #: S63771
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Infections

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