Recognition of Serious Infections in the Elderly (ROSIE)

• ClinicalTrials.gov Identifier: NCT04516187
• Recruitment Status: Recruiting
• First Posted: August 18, 2020
• Last Update Posted: January 20, 2022
• Sponsor: KU Leuven
• Information provided by (Responsible Party): Ann Van den Bruel, KU Leuven

Study Description

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 across Flanders (Belgium).

Condition or disease	Intervention/treatment
Infection	Diagnostic Test: signs and symptoms, blood tests

Detailed Description:

This is a cross-sectional diagnostic cohort study in older adults presenting to primary 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 general practices in Flanders. Recruitment is expected to last 20 months, 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 general practice notes (EMD) and patient diaries.

Treatment and other management decisions will be left to the treating physicians' discretion.

If we are unable to reach our predefined sample size in primary care, we will also start recruitment at emergency departments. In that case, we will send an amendment to this protocol to the involved ethics committees.

Study Design

• Study Type: Observational
• Estimated Enrollment: 1170 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Actual Study Start Date: October 16, 2020
• Estimated Primary Completion Date: March 30, 2023
• Estimated Study Completion Date: April 30, 2023

Groups and Cohorts

Intervention Details:

• Diagnostic Test: signs and symptoms, blood tests
  signs and symptoms as observed by the treating GP, blood tests (CRP, Procalcitonin, White blood cell count)

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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 Outcome Measures:

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

Biospecimen Retention:   Samples With DNA

Blood serum

Eligibility Criteria

• Ages Eligible for Study: 65 Years and older (Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

All acutely ill adults aged 65 years or older presenting to primary care in whom a physician suspects an infection will be eligible. Primary care is defined as in-hours general practice.

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)
• Patient was already included in the study

Contacts and Locations

Contacts

Contact: Thomas Struyf, MS; +32495280329; thomas.struyf@kuleuven.be

Contact: Ann Van den Bruel, MD, PhD; ann.vandenbruel@kuleuven.be

Locations

Belgium

De Driehoek Paal; Recruiting

Paal, Limburg, Belgium, 3583

Contact: Ilse Jeurissen, MD

Principal Investigator: Ilse Jeurissen, MD

Sub-Investigator: Steffi Boekaerts, MD

Sub-Investigator: Cerdic De Vries, MD

De Wijkpraktijk; Recruiting

Antwerp, Belgium

Contact: Ann Van den Bruel, MD, PhD

Sub-Investigator: Bram Spinnewijn, MD

Sub-Investigator: Katrien Cordemans, MD

Sub-Investigator: Viktor Lannoy, MD

Sub-Investigator: Stéphanie Janssens, MD

Principal Investigator: Ann Van den Bruel, MD, PhD

Dr. Raes; Recruiting

Antwerp, Belgium

Contact: Wim Raes, MD

Principal Investigator: Wim Raes, MD

Eliaerts; Recruiting

Borgerhout, Belgium

Contact: Liselore De Rop, MD

Principal Investigator: Liselore De Rop, MD

De Leeuwenkaart; Recruiting

Brasschaat, Belgium

Contact: Danielle Van Bruggen, MD

Sub-Investigator: Jeroen Anthierens, MD

Sub-Investigator: Marianne Looten, MD

Principal Investigator: Danielle Van Bruggen, MD

De Bilter 28; Recruiting

Heers, Belgium

Contact: Frederik Ponet, MD

Sub-Investigator: Sofie Bourguignon, MD

Sub-Investigator: Liesbeth Baens, MD

Principal Investigator: Frederik Ponet, MD

Dr. Borremans; Recruiting

Hemiksem, Belgium

Contact: Vanessa Borremans, MD

Principal Investigator: Vanessa Borremans, MD

Emergency Department University Hospitals Leuven; Recruiting

Leuven, Belgium

Contact: Stefanie Grewe, MSc

Principal Investigator: Marc Sabbe, MD, PhD

Emergency Department St.-Jozef Hospital Malle; Recruiting

Malle, Belgium

Contact: Elien Anthonissen, MSc

Principal Investigator: Nicolas Leonard, MD

Huisartsencentrum Millegem; Recruiting

Mol, Belgium

Contact: Patrick Coursier, MD

Sub-Investigator: Valérie Goossens, MD

Sub-Investigator: Tinne Wuyts, MD

Sub-Investigator: Laura Cuinen, MD

Sub-Investigator: Geert Potloot, MD

Sub-Investigator: Arne Van Roey, MD

Principal Investigator: Patrick Coursier, MD

DRLA; Recruiting

Mortsel, Belgium

Contact: Martine Lembregts, MD

Principal Investigator: Martine Lembregts, MD

De Driehoek Paal; Recruiting

Paal, Belgium

Contact: Lies Vanderperre, MD

Sub-Investigator: Evelien Holsteyns, MD

Sub-Investigator: Zeno Goos, MD

Principal Investigator: Lien Vanderperre, MD

De Midgaard; Recruiting

Rotselaar, Belgium

Contact: Willem Raat, MD

Principal Investigator: Willem Raat, MD

Huisartsenpraktijk Tremelo; Recruiting

Tremelo, Belgium

Contact: Olivia Vandeput, MD

Sub-Investigator: Mattia Merckx, MD

Sub-Investigator: Sarah Lee Selleslagh, MD

Sub-Investigator: Erik Schreurs, MD

Principal Investigator: Olivia Vandeput, MD

Onspraktijk; Recruiting

Wilrijk, Belgium

Contact: Joke Bernagie, MD

Sub-Investigator: Julie Domen, MD

Principal Investigator: Joke Bernagie, MD

Sponsors and Collaborators

KU Leuven

Investigators

• Principal Investigator: Ann Van den Bruel, MD, PhD; Department of Public Health and Primary Care, KU leuven

More Information

• Responsible Party: Ann Van den Bruel, Professor, KU Leuven
• ClinicalTrials.gov Identifier: NCT04516187
• Other Study ID Numbers: S63771
• First Posted: August 18, 2020
• Last Update Posted: January 20, 2022
• Last Verified: January 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ann Van den Bruel, KU Leuven:

geriatric; diagnosis; ambulatory care; general practice

Additional relevant MeSH terms:

Infections; Communicable Diseases; Disease Attributes; Pathologic Processes