InfectionERNIE4NCT03835104
ERNIE4: Urine and CRP Point-of-care Test in Acutely Ill Children
A study testing CRP point-of-care testing in people with Infection, run by KU Leuven at 1 site in Belgium.
Trial summary
This study aims to assess the accuracy of a novel urine test for diagnosing urinary tract infections in acutely ill children presenting to ambulatory care. The accuracy of this novel test will be compared to the accuracy of conventional dipstick testing. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Infection
- What is being tested?
- CRP point-of-care testing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 868 participants
- Where
- 1 siteBelgium
- Study dates
- 12 Feb 2019to 22 May 2020
- Phase
- Interventional
- 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 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Aged 3 months to 18 years
- Presenting to a general practice or community paediatrics
- Acute illness of a maximum of 10 days
- Parent or guardian is willing and able to give informed consent for participation
Who cannot join
- Clinically unstable warranting immediate care
- Urinary catheter in situ
- Immunosuppressant medication taken in the previous 30 days
- Trauma is the main presenting problem
- Antibiotics taken in the previous 7 days
- Children who present to community paediatrics as a result of direct GP referral
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Urine and CRP Tests at the Point-of-care for the Diagnostic Assessment of Acutely Ill Children: a Diagnostic and Prognostic Study
This study aims to assess the accuracy of a novel urine test for diagnosing urinary tract infections in acutely ill children presenting to ambulatory care. The accuracy of this novel test will be compared to the accuracy of conventional dipstick testing. In addition, the evidence on urine tests will be added to the existing algorithm for diagnosing serious infections in children. Finally, the study aims to describe the relation between the CRP level at study entry and the duration of symptoms and final diagnosis over the following 30 days.
Read the detailed description
The design is a cross-sectional cohort study with a nested longitudinal follow-up in acutely children presenting to ambulatory care.
The cross-sectional cohort study will compare an innovative urine test with conventional dipstick testing to establish their relative accuracy to diagnose urinary tract infections, and construct an algorithm consisting of clinical features, urine test results and CRP point-of-care testing to identify serious infections. The longitudinal follow-up study will describe illness trajectories of children with an intermediate CRP test result (5-80 mg/L) at first contact.
The study will run in general practices and community paediatrics in Flanders. Recruitment to the study is expected to last 18 months, with each patient entering the study only once. Children and their parents/guardians will be approached for possible participation in the study by practice staff. There is only one study visit.
Those who agree to participation via written informed consent will have demographics and clinical features recorded. All children will be asked to provide a urine sample on study entry. Subsequently, CRP point-of-care testing will be conducted in all children testing positive on a clinical prediction rule, and in a random sample of children testing negative on that rule. Follow-up information for all children will be collected using general practice notes, hospital records and direct patient/parent contact.
Treatment and other management decisions will be left to the treating physicians' discretion.
- Conditions
- Infection
- Being tested
- CRP point-of-care testing
- Keywords
- diagnosis, sensitivity and specificity, serious infections
- Medical subject headings
- Infections, Disease, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRP point-of-care testingDevice
CRP point-of-care test using a fingerprick of blood and producing a result within 4 minutes, using the Afinion 2 (Abbott)
| Study group | Role | What they receive |
|---|---|---|
| CRP in all | Active comparator | All children will undergo a CRP point-of-care test using a fingerprick of blood and producing a result within 4 minutes using the Afinion 2 (Abbott).
There will be only 1 test at study entry Receives: Device: CRP point-of-care testing |
| CRP in high risk children only | Experimental | Children who are positive on a clinical prediction rule for serious infections in children will undergo CRP point-of-care test using a fingerprick of blood and producing a result within 4 minutes using the Afinion 2 (Abbott).
There will be only 1 test at study entry Receives: Device: CRP point-of-care testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary tract infection
The number of children with a urinary tract infection based on urine culture
Measured: 3 days
Secondary outcomes (1)
Serious infections
The number of children admitted to hospital for a serious infection which can be pneumonia, sepsis, meningitis, pyelonephritis, osteomyelitis or appendicitis
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 posted8 Feb 2019
- Study start12 Feb 2019
- Primary completion22 May 2020
- Study completion22 May 2020
Why it stopped: Covid pandemic caused recruitment to stop
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is a cluster randomized controlled trial. The general practice is the unit of cluster.
- Masking
- None (open label)
- Enrolment
- 868 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, ACHG, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03835104
- Sponsor's protocol ID
- S61991
- Acronym
- ERNIE4
- Status last verified
- May 2021
- First submitted
- 29 Jan 2019
- Last updated
- 3 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Any invitations for data sharing will be assessed on scientific validity, after which a decision will be taken.
Publications
Boon HA, De Burghgraeve T, Verbakel JY, Van den Bruel A. Point-of-care tests for pediatric urinary tract infections in general practice: a diagnostic accuracy study. Fam Pract. 2022 Jul 19;39(4):616-622. doi: 10.1093/fampra/cmab118.
PubMed 34633441
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urine and CRP Tests at the Point-of-care for the Diagnostic Assessment of Acutely Ill Children: a Diagnostic and Prognostic Study
- ClinicalTrials.gov ID
- NCT03835104
- Acronym / sponsor ID
- ERNIE4 / S61991
- Conditions
- Infection
- Keywords
- diagnosis, sensitivity and specificity, serious infections
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Covid pandemic caused recruitment to stop
- Enrolment
- 868 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 12 Feb 2019 (actual)
- Primary completion
- 22 May 2020 (actual)
- Study completion
- 22 May 2020 (actual)
- First posted
- 8 Feb 2019 (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.
This study aims to assess the accuracy of a novel urine test for diagnosing urinary tract infections in acutely ill children presenting to ambulatory care. The accuracy of this novel test will be compared to the accuracy of conventional dipstick testing. In addition, the evidence on urine tests will be added to the existing algorithm for diagnosing serious infections in children. Finally, the study aims to describe the relation between the CRP level at study entry and the duration of symptoms and final diagnosis over the following 30 days.
Detailed description
The design is a cross-sectional cohort study with a nested longitudinal follow-up in acutely children presenting to ambulatory care.
The cross-sectional cohort study will compare an innovative urine test with conventional dipstick testing to establish their relative accuracy to diagnose urinary tract infections, and construct an algorithm consisting of clinical features, urine test results and CRP point-of-care testing to identify serious infections. The longitudinal follow-up study will describe illness trajectories of children with an intermediate CRP test result (5-80 mg/L) at first contact.
The study will run in general practices and community paediatrics in Flanders. Recruitment to the study is expected to last 18 months, with each patient entering the study only once. Children and their parents/guardians will be approached for possible participation in the study by practice staff. There is only one study visit.
Those who agree to participation via written informed consent will have demographics and clinical features recorded. All children will be asked to provide a urine sample on study entry. Subsequently, CRP point-of-care testing will be conducted in all children testing positive on a clinical prediction rule, and in a random sample of children testing negative on that rule. Follow-up information for all children will be collected using general practice notes, hospital records and direct patient/parent contact.
Treatment and other management decisions will be left to the treating physicians' discretion.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study is a cluster randomized controlled trial. The general practice is the unit of cluster.
| Arm | Type | Receives |
|---|---|---|
| CRP in all | Active comparator | Device: CRP point-of-care testingAll children will undergo a CRP point-of-care test using a fingerprick of blood and producing a result within 4 minutes using the Afinion 2 (Abbott). There will be only 1 test at study entry |
| CRP in high risk children only | Experimental | Device: CRP point-of-care testingChildren who are positive on a clinical prediction rule for serious infections in children will undergo CRP point-of-care test using a fingerprick of blood and producing a result within 4 minutes using the Afinion 2 (Abbott). There will be only 1 test at study entry |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Aged 3 months to 18 years
- Presenting to a general practice or community paediatrics
- Acute illness of a maximum of 10 days
- Parent or guardian is willing and able to give informed consent for participation
Key exclusion criteria (6 listed)
- Clinically unstable warranting immediate care
- Urinary catheter in situ
- Immunosuppressant medication taken in the previous 30 days
- Trauma is the main presenting problem
- Antibiotics taken in the previous 7 days
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 |
|---|---|---|
| CRP point-of-care testingCRP point-of-care test using a fingerprick of blood and producing a result within 4 minutes, using the Afinion 2 (Abbott) | Device | CRP in all, CRP in high risk children only |
Primary outcome
Urinary tract infection
Time frame: 3 days
The number of children with a urinary tract infection based on urine culture
1 secondary outcome
Serious infections
Time frame: 30 days
Results and safety
The study was stopped early (reason given: Covid pandemic caused recruitment to stop). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2021.
- Derived from this study: PubMed 34633441Boon HA, De Burghgraeve T, Verbakel JY, Van den Bruel A. Point-of-care tests for pediatric urinary tract infections in general practice: a diagnostic accuracy study. Fam Pract. 2022 Jul 19;39(4):616-622. doi: 10.1093/fampra/cmab118.
- Individual participant dataSharing planned: Undecided. Any invitations for data sharing will be assessed on scientific validity, after which a decision will be taken.
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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
ACHG, KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CRP point-of-care testing in people with Infection, run by KU Leuven at 1 site 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 6 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: stopped early, as of the sponsor's last update on 3 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was stopped early (reason given: Covid pandemic caused recruitment to stop). Results are not available in the source record.
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?
Urinary tract infection (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03835104, which also lists 1 linked publication.
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 3 Jun 2021.