NCT04516187

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
493

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Typical duration for all trials

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2020

Completed
19 days until next milestone

First Posted

Study publicly available on registry

August 18, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

October 16, 2020

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 3, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 3, 2023

Completed
Last Updated

August 7, 2023

Status Verified

August 1, 2023

Enrollment Period

2.8 years

First QC Date

July 30, 2020

Last Update Submit

August 3, 2023

Conditions

Infection

Keywords

geriatricdiagnosisambulatory caregeneral practiceemergency care

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Diagnostic accuracy 2

    30 days

Other Outcomes (6)

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

    30 days

  • Diagnostic accuracy 3

    30 days

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

    30 days

  • +3 more other outcomes

Study Arms (2)

Emergency care

Consecutive enrolment of acutely ill older adults in emergency care

Diagnostic Test: signs and symptoms, blood tests

General practice

Consecutive enrolment of acutely ill older adults in general practice

Diagnostic Test: signs and symptoms, blood tests

Interventions

signs and symptoms, blood testsDIAGNOSTIC_TEST

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

Emergency careGeneral practice

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

De Driehoek Paal

Paal, Limburg, 3583, Belgium

Location

De Wijkpraktijk

Antwerp, Belgium

Location

De Leeuwenkaart

Brasschaat, Belgium

Location

Huisartsenpraktijk Arcade

Gelrode, Belgium

Location

De Bilter 28

Heers, Belgium

Location

Emergency Department Heilig Hart hospital Leuven

Leuven, Belgium

Location

Emergency Department University Hospitals Leuven

Leuven, Belgium

Location

Emergency Department St.-Jozef Hospital Malle

Malle, Belgium

Location

DRLA

Mortsel, Belgium

Location

De Driehoek Paal

Paal, Belgium

Location

Huisartspraktijk Brustempoort

Sint-Truiden, Belgium

Location

Onspraktijk

Wilrijk, Belgium

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood serum

MeSH Terms

Conditions

InfectionsDisease

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Ann Van den Bruel, MD, PhD

    Department of Public Health and Primary Care, KU leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 30, 2020

First Posted

August 18, 2020

Study Start

October 16, 2020

Primary Completion

August 3, 2023

Study Completion

August 3, 2023

Last Updated

August 7, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

BE(12)