Clinical trial NCT04516187: Recognition of Serious Infections in the Elderly
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infection
Keywords: geriatric
diagnosis
ambulatory care
general practice
emergency care
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2020-08-18
Enrollment: 493
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All acutely ill adults aged 65 years or older presenting to ambulatory care in whom a physician suspects an infection will be eligible. Ambulatory care is defined as in-hours general practice and emergency care.

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Diagnostic accuracy 1
timeFrame: 30 days
Secondary outcomes:
measure: Diagnostic accuracy 2
timeFrame: 30 days
Other outcomes:
measure: Net benefit: number of patients correctly classified as having a serious infection
timeFrame: 30 days
measure: Diagnostic accuracy 3
timeFrame: 30 days
measure: Descriptive 1: Prevalence (%) of serious infections in the study population
timeFrame: 30 days
measure: Descriptive 2: multivariate analysis (no outcome)
timeFrame: 30 days
measure: Diagnostic accuracy 4
timeFrame: 30 days
measure: Diagnostic accuracy, sensitivity analysis
timeFrame: 30 days
Locations:
city: Paal
country: Belgium
facility: De Driehoek Paal
state: Limburg
city: Antwerp
country: Belgium
facility: De Wijkpraktijk
city: Brasschaat
country: Belgium
facility: De Leeuwenkaart
city: Gelrode
country: Belgium
facility: Huisartsenpraktijk Arcade
city: Heers
country: Belgium
facility: De Bilter 28
city: Leuven
country: Belgium
facility: Emergency Department Heilig Hart hospital Leuven
city: Leuven
country: Belgium
facility: Emergency Department University Hospitals Leuven
city: Malle
country: Belgium
facility: Emergency Department St.-Jozef Hospital Malle
city: Mortsel
country: Belgium
facility: DRLA
city: Paal
country: Belgium
facility: De Driehoek Paal
city: Sint-Truiden
country: Belgium
facility: Huisartspraktijk Brustempoort
city: Wilrijk
country: Belgium
facility: Onspraktijk
Study officials:
affiliation: Department of Public Health and Primary Care, KU leuven
name: Ann Van den Bruel, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: