InfectionROSIENCT04516187
Recognition of Serious Infections in the Elderly
An observational study of Infection, run by KU Leuven at 12 sites in Belgium.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Infection
- What is being tested?
- signs and symptoms, blood tests
- How many people
- 493 participants
- Where
- 12 sitesBelgium
- Study dates
- 16 Oct 2020to 3 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Belgium12 sites
De Wijkpraktijk
Antwerp
De Leeuwenkaart
Brasschaat
Huisartsenpraktijk Arcade
Gelrode
De Bilter 28
Heers
Emergency Department Heilig Hart hospital Leuven
Leuven
Emergency Department University Hospitals Leuven
Leuven
Emergency Department St.-Jozef Hospital Malle
Malle
DRLA
Mortsel
De Driehoek Paal
Paal, Limburg, 3583
De Driehoek Paal
Paal
Huisartspraktijk Brustempoort
Sint-Truiden
Onspraktijk
Wilrijk
About this study
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
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).
Read the 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.
- Conditions
- Infection
- Being tested
- signs and symptoms, blood tests
- Keywords
- geriatric, diagnosis, ambulatory care, general practice, emergency care
- Medical subject headings
- Infections, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
signs and symptoms, blood testsDiagnostic test
signs and symptoms as observed by the treating physician + blood tests (CRP, Procalcitonin, White blood cell count)
| Study group | Role | What they receive |
|---|---|---|
| Emergency care | Consecutive enrolment of acutely ill older adults in emergency care Receives: Diagnostic Test: signs and symptoms, blood tests | |
| General practice | Consecutive enrolment of acutely ill older adults in general practice Receives: Diagnostic Test: signs and symptoms, blood tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days
Secondary outcomes (1)
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
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2020
- Study start16 Oct 2020
- Primary completion3 Aug 2023
- Study completion3 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 493 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ann Van den Bruel, KU Leuven
- Investigators
- Ann Van den Bruel, MD, PhD, Principal investigator, Department of Public Health and Primary Care, KU leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04516187
- Sponsor's protocol ID
- S63771
- Acronym
- ROSIE
- Status last verified
- Aug 2023
- First submitted
- 30 Jul 2020
- Last updated
- 7 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04516187
- Acronym / sponsor ID
- ROSIE / S63771
- Conditions
- Infection
- Keywords
- geriatric, diagnosis, ambulatory care, general practice, emergency care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 493 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 16 Oct 2020 (actual)
- Primary completion
- 3 Aug 2023 (actual)
- Study completion
- 3 Aug 2023 (actual)
- First posted
- 18 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Emergency care | – | Diagnostic Test: signs and symptoms, blood testsConsecutive enrolment of acutely ill older adults in emergency care |
| General practice | – | Diagnostic Test: signs and symptoms, blood testsConsecutive enrolment of acutely ill older adults in general practice |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| signs and symptoms, blood testssigns and symptoms as observed by the treating physician + blood tests (CRP, Procalcitonin, White blood cell count) | Diagnostic test | Emergency care, General practice |
Primary outcome
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
1 secondary outcome
Diagnostic accuracy 2
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann Van den Bruel, MD, PhD principal investigator
Department of Public Health and Primary Care, KU leuven
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infection, run by KU Leuven at 12 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy 1 (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2023.