InfectionARONNCT04470518
Impact of Clinical Guidance & Point-of-care CRP in Children: the ARON Project
A study testing diagnostic algorithm in people with Infection, run by KU Leuven at 1 site in Belgium.
Trial summary
Impact of clinical guidance \& point-of-care CRP test in children: the ARON project Trial Design: multicentre, cluster-randomized, parallel group pragmatic trial Trial Participants and setting: Children aged 6 months to 12 years of age with an acute illness episode presenting to in-hours general practice or… Read more about this study
- Who is it for?
- Ages 6 months to 12 years
- Conditions the study is for
- Infection
- What is being tested?
- diagnostic algorithm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,750 participants
- Where
- 1 siteBelgium
- Study dates
- 6 Jan 2021to 24 Apr 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 6 months to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Being able to recruit acutely ill children (ideally consecutively)
- Agree to the terms of the clinical study agreement.
- Children aged 6 months to 12 years, provided informed consent can be obtained
- presenting with an acute illness episode that started maximum 10 days before the index consultation
Who cannot join
- Currently using a POC CRP device as part of their routine care
- No practices will be excluded on other grounds than the above. Age, demographics, geographic region will not be used to exclude eligible practices. This will provide us with a real-life, representative subset of ambulatory care physicians.
- Children who were previously included in this trial
- children with an underlying known chronic condition (e.g. asthma, immune deficiency)
- clinically unstable warranting immediate care
- immunosuppressant medication taken in the previous 30 days
Show all 9Show fewer
- trauma as the main presenting problem
- antibiotics taken in the previous 7 days
- Unwillingness or inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of a Diagnostic Algorithm on Antibiotic Prescribing Rate and Further Management of Acutely Ill Children Presenting to Ambulatory Care: Multicentre, Cluster-randomized, Parallel Group Pragmatic Trial
Impact of clinical guidance \& point-of-care CRP test in children: the ARON project Trial Design: multicentre, cluster-randomized, parallel group pragmatic trial Trial Participants and setting: Children aged 6 months to 12 years of age with an acute illness episode presenting to in-hours general practice or out-of-hospital community paediatrics offices
Intervention(s) Diagnostic algorithm:
Read more
- Clinical decision tree: clinician's gut feeling something is wrong, dyspnea, temperature ≥40ºC
- YES to any : point-of-care CRP ≥5mg/L: additional testing or refer to secondary care <5mg/L: safety netting*, only prescribe antibiotics if advised (guidelines)
- NO to all : are AB considered? YES : point-of-care CRP ≥5mg/L: safety netting*, only prescribe antibiotics if advised (guidelines) <5mg/L: safety netting*, do not prescribe antibiotics NO: safety netting *safety netting advice:
- inform parents on what to expect and what to look out for
- interactive parent information booklet based on previous research Control: Diagnosis and Treatment/Management as per usual care:
- guidance on AB prescribing:
- Belgische Commissie voor de Coördinatie van het Antibioticabeleid (BAPCOC) guide (updated November 2019)
- RIZIV consensus meeting report "Antibiotics in children in ambulatory care" Primary Endpoint: Antibiotic prescribing rate at index consultation Secondary Endpoint(s)
- time until full clinical recovery (during follow up (day 1 to day 30))
- additional investigations (at index consultation and/or during follow up (day 1 to day 30))
- re-consultation (during follow up (day 1 to day 30))
- antibiotic prescribing rate (during follow up (day 1 to day 30)) Exploratory endpoints at the index consultation:
- additional investigations (X-Ray, blood tests, urine tests, etc.) During a follow-up period (day 1 to day 30):
- referral to hospital
- additional investigations (X-Ray, blood tests, urine tests, etc.)
- patients with full clinical recovery at day 7 and day 30
- admission to hospital
- mortality
- cost-effectiveness
- patient satisfaction
- qualitative study: endpoints Planned Sample Size: 7000 Timing of the intervention: Intervention at index consultation (at presentation to primary care) Follow-up duration: 30 days follow-up Duration of the trial (FPI-CSR): 43 months
Read the detailed description
The investigators aim to strengthen the assessment of acutely ill children in primary care, by introducing a diagnostic algorithm that can decrease antibiotic prescribing.
In light of the prior evidence and its results so far, the ARON trial will test the impact of a diagnostic algorithm including a standardised clinical assessment, a POC CRP test, and safety netting advice.
Therefore, the investigators propose to assess the clinical and cost-effectiveness of a diagnostic algorithm which includes a decision tree, POC CRP and safety netting advice in acutely ill children aged 6 months to 12 years of age presenting to ambulatory care, on AB prescribing, referral/admission to hospital, additional testing, mortality, and patient satisfaction.
More specifically, the investigators' research question is whether this diagnostic algorithm is able to safely reduce antibiotic prescribing in acutely ill children presenting to ambulatory care.
The decision whether or not to conduct a POC CRP test will depend on the standardized clinical assessment, i.e. a validated clinical decision tree, and subsequently for low-risk children on the intention to prescribe AB.
The investigators will provide clear evidence-based guidance on how to interpret the CRP test result as outlined below.
A process evaluation will examine how clinicians use CRP testing in their practice and how parents experience these consultations.
The investigators propose a study, where children (6 months to 12 years of age) will be randomised to (a) a diagnostic algorithm with CRP testing and specific guidance on when to prescribe AB or (b) usual care. CRP testing will be done using a finger prick test (result within 4 minutes). The CRP level will then be given to the clinician who will communicate the result to the child/parents.
The investigators aim to recruit 7000 children and will collect data registered by the participating physician, from the child's health record and children/parents directly. The investigators will describe how the intervention has worked in practice and how clinicians/parents have experienced these consultations.
Guidance will be part of a diagnostic algorithm which includes clinically guided POC CRP testing and safety netting advice to inform parents on what to expect and what to look out for.
Individual interviews will be conducted with clinicians and parents taking part in the trial within 30 days after the first contact consultation, to explore the social processes influencing embedding of the intervention within practice, and behaviour change techniques.
These individual telephone interviews will be performed with a selection of parents to address whether their concerns were discussed appropriately and whether their expectations were met and how they experienced the consultation and/or POC CRP testing.
The safety-netting advice will be supported by a parent information booklet, based on previous research (the "When should I worry"-interactive booklet (a guide to Coughs, Colds, Earache \& Sore Throats), the "Mijn kind heeft koorts" booklet (Eefje de Bont, www.thuisarts.nl), and the "Caring for children with coughs"-leaflet (information about how to look after a child who has a cough and when to see the doctor)).
The findings of this study could change the practice of ambulatory care physicians and might be of great interest to parents and childcare providers. The investigators will publish the findings of this research in academic journals, present at national conferences and discuss results with groups responsible for the national guidance on how to assess acutely ill children (Domus Medica, SSMG).
- Conditions
- Infection
- Being tested
- diagnostic algorithm
- Keywords
- antibiotic prescription, infections, decision tree, point-of-care C-reactive protein test, safetynet advice
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diagnostic algorithmOther
Guidance will be part of a diagnostic algorithm which includes clinically guided point-of-care C-reactive protein testing and safety netting advice to inform parents on what to expect and what to look out for. A selection of clinical features will be assessed and recorded by the physician in the patient's health record and on the e-CRF, including the clinical decision tree (clinician's gut feeling, body temperature, dyspnea).
The safety-netting advice will be supported by a parent information booklet, based on previous research (the "When should I worry"-interactive booklet (a guide to Coughs, Colds, Earache \& Sore Throats), the "Mijn kind heeft koorts" booklet (Eefje de Bont, www.thuisarts.nl), and the "Caring for children with coughs"-leaflet (information about how to look after a child who has a cough and when to see the doctor)).
| Study group | Role | What they receive |
|---|---|---|
| Intervention: Diagnostic algorithm | Active comparator | diagnostic algorithm including a standardised clinical assessment, a Point-of-care C-reactive protein test, and safety netting advice Receives: Other: diagnostic algorithm |
| Usual care | No intervention | In the control arm, patients will receive 'usual care' left at the discretion of the treating physician. Apart from the general training session for all participating physicians they have attended prior to recruitment and randomization, physicians in the control arm will not receive additional tools. They are expected (but not forced) to follow the Belgian guidelines (as described in "BAPCOC National guidelines and the RIZIV consensus meeting "Rational use of antibiotics in children"). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibiotic Prescribing Rate at Index Consultation (Immediate or Delayed)
The primary outcome is the percentage of participants who were prescribed antibiotic treatment (both immediate and delayed) at the index consultation as recorded by the treating physician.
Measured: This outcome will be registered immediately at the index consultation (immediately after the intervention)
Secondary outcomes (4)
Clinical Recovery During Follow-up
the duration (in days) until reaching full clinical recovery
Measured: This outcome will be checked from the diary (via app for parents) from first day after the intervention until day of full clinical recovery (up to maximum 30 days after after the intervention)
Additional Investigations at Index Consultation and/or During Follow-up
the percentage of subjects receiving additional testing (including, but not limited to (X-Ray, blood tests, urine tests) at index consultation (day 0) and/or during follow-up (day 1 to day 30)
Measured: This composite outcome will be registered immediately after the intervention and/or checked from the patient health record from the first day to day 30 after the intervention
Re-consultation During Follow-up
percentage of subjects who re-consulted their physician during follow-up (day 1 to day 30)
Measured: This outcome will be checked from the patient health record from first day to day 30 after the intervention
Antibiotic Prescribing Rate During Follow-up
percentage of subjects who were prescribed antibiotic treatment during follow-up (day 1 to day 30)
Measured: This outcome will be checked from the patient health record first day to day 30 after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start6 Jan 2021
- Primary completion1 Feb 2024
- Study completion24 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- multicentre, cluster-randomized, parallel group pragmatic trial
- Masking
- None (open label)
- Enrolment
- 6,750 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven, University Ghent, Universiteit Antwerpen, University of Liege, Vrije Universiteit Brussel, Université Catholique de Louvain
- Responsible party
- Principal investigator, Jan Verbakel, KU Leuven
- Investigators
- Jan Y Verbakel, MD, PhD, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04470518
- Sponsor's protocol ID
- S62005
- Acronym
- ARON
- Status last verified
- Apr 2025
- First submitted
- 2 Jul 2020
- Last updated
- 23 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual patient data from this trial will not be published in the public domain. Deidentified participant data is available for further analyses. Requests for data, with justification, should be sent to Jan Verbakel (Jan . verbakel @ kuleuven.be, Tine De Burghgraeve (tine . deburghgraeve @ kuleuven.be. The trial protocol is available online for an indefinite period.
Publications
Verbakel JY, Lemiengre MB, De Burghgraeve T, De Sutter A, Aertgeerts B, Bullens DMA, Shinkins B, Van den Bruel A, Buntinx F. Point-of-care C reactive protein to identify serious infection in acutely ill children presenting to hospital: prospective cohort study. Arch Dis Child. 2018 May;103(5):420-426. doi: 10.1136/archdischild-2016-312384. Epub 2017 Dec 21.
PubMed 29269559Verbakel JY, Aertgeerts B, Lemiengre M, Sutter AD, Bullens DM, Buntinx F. Analytical accuracy and user-friendliness of the Afinion point-of-care CRP test. J Clin Pathol. 2014 Jan;67(1):83-6. doi: 10.1136/jclinpath-2013-201654. Epub 2013 Sep 11. No abstract available.
PubMed 24025452Verbakel JY, Lemiengre MB, De Burghgraeve T, De Sutter A, Aertgeerts B, Shinkins B, Perera R, Mant D, Van den Bruel A, Buntinx F. Should all acutely ill children in primary care be tested with point-of-care CRP: a cluster randomised trial. BMC Med. 2016 Oct 6;14(1):131. doi: 10.1186/s12916-016-0679-2.
PubMed 27716201Verbakel JY, Burvenich R, D'hulster E, De Rop L, Van den Bruel A, Anthierens S, Coenen S, De Sutter A, Heytens S, Joly L, Digregorio M, Laenen A, Luyten J, De Burghgraeve T. A clinical decision tool including a decision tree, point-of-care testing of CRP, and safety-netting advice to guide antibiotic prescribing in acutely ill children in primary care in Belgium (ARON): a pragmatic, cluster-randomised, controlled trial. Lancet. 2025 Oct 11;406(10512):1599-1610. doi: 10.1016/S0140-6736(25)01239-5. Epub 2025 Sep 25.
PubMed 41016406Verbakel JYJ, De Burghgraeve T, Van den Bruel A, Coenen S, Anthierens S, Joly L, Laenen A, Luyten J, De Sutter A. Antibiotic prescribing rate after optimal near-patient C-reactive protein testing in acutely ill children presenting to ambulatory care (ARON project): protocol for a cluster-randomized pragmatic trial. BMJ Open. 2022 Jan 3;12(1):e058912. doi: 10.1136/bmjopen-2021-058912.
PubMed 34980633
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Diagnostic Algorithm on Antibiotic Prescribing Rate and Further Management of Acutely Ill Children Presenting to Ambulatory Care: Multicentre, Cluster-randomized, Parallel Group Pragmatic Trial
- ClinicalTrials.gov ID
- NCT04470518
- Acronym / sponsor ID
- ARON / S62005
- Conditions
- Infection
- Keywords
- antibiotic prescription, infections, decision tree, point-of-care C-reactive protein test, safetynet advice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,750 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven, University Ghent, Universiteit Antwerpen, University of Liege, Vrije Universiteit Brussel, Université Catholique de Louvain
- Study start
- 6 Jan 2021 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 24 Apr 2024 (actual)
- First posted
- 14 Jul 2020 (actual)
- Results
- Posted 23 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Impact of clinical guidance \& point-of-care CRP test in children: the ARON project Trial Design: multicentre, cluster-randomized, parallel group pragmatic trial Trial Participants and setting: Children aged 6 months to 12 years of age with an acute illness episode presenting to in-hours general practice or out-of-hospital community paediatrics offices
Intervention(s) Diagnostic algorithm:
- Clinical decision tree: clinician's gut feeling something is wrong, dyspnea, temperature ≥40ºC
- YES to any : point-of-care CRP ≥5mg/L: additional testing or refer to secondary care <5mg/L: safety netting*, only prescribe antibiotics if advised (guidelines)
- NO to all : are AB considered? YES : point-of-care CRP ≥5mg/L: safety netting*, only prescribe antibiotics if advised (guidelines) <5mg/L: safety netting*, do not prescribe antibiotics NO: safety netting *safety netting advice:
- inform parents on what to expect and what to look out for
- interactive parent information booklet based on previous research Control: Diagnosis and Treatment/Management as per usual care:
- guidance on AB prescribing:
- Belgische Commissie voor de Coördinatie van het Antibioticabeleid (BAPCOC) guide (updated November 2019)
- RIZIV consensus meeting report "Antibiotics in children in ambulatory care" Primary Endpoint: Antibiotic prescribing rate at index consultation Secondary Endpoint(s)
- time until full clinical recovery (during follow up (day 1 to day 30))
- additional investigations (at index consultation and/or during follow up (day 1 to day 30))
- re-consultation (during follow up (day 1 to day 30))
- antibiotic prescribing rate (during follow up (day 1 to day 30)) Exploratory endpoints at the index consultation:
- additional investigations (X-Ray, blood tests, urine tests, etc.) During a follow-up period (day 1 to day 30):
- referral to hospital
- additional investigations (X-Ray, blood tests, urine tests, etc.)
- patients with full clinical recovery at day 7 and day 30
- admission to hospital
- mortality
- cost-effectiveness
- patient satisfaction
- qualitative study: endpoints Planned Sample Size: 7000 Timing of the intervention: Intervention at index consultation (at presentation to primary care) Follow-up duration: 30 days follow-up Duration of the trial (FPI-CSR): 43 months
Detailed description
The investigators aim to strengthen the assessment of acutely ill children in primary care, by introducing a diagnostic algorithm that can decrease antibiotic prescribing.
In light of the prior evidence and its results so far, the ARON trial will test the impact of a diagnostic algorithm including a standardised clinical assessment, a POC CRP test, and safety netting advice.
Therefore, the investigators propose to assess the clinical and cost-effectiveness of a diagnostic algorithm which includes a decision tree, POC CRP and safety netting advice in acutely ill children aged 6 months to 12 years of age presenting to ambulatory care, on AB prescribing, referral/admission to hospital, additional testing, mortality, and patient satisfaction.
More specifically, the investigators' research question is whether this diagnostic algorithm is able to safely reduce antibiotic prescribing in acutely ill children presenting to ambulatory care.
The decision whether or not to conduct a POC CRP test will depend on the standardized clinical assessment, i.e. a validated clinical decision tree, and subsequently for low-risk children on the intention to prescribe AB.
The investigators will provide clear evidence-based guidance on how to interpret the CRP test result as outlined below.
A process evaluation will examine how clinicians use CRP testing in their practice and how parents experience these consultations.
The investigators propose a study, where children (6 months to 12 years of age) will be randomised to (a) a diagnostic algorithm with CRP testing and specific guidance on when to prescribe AB or (b) usual care. CRP testing will be done using a finger prick test (result within 4 minutes). The CRP level will then be given to the clinician who will communicate the result to the child/parents.
The investigators aim to recruit 7000 children and will collect data registered by the participating physician, from the child's health record and children/parents directly. The investigators will describe how the intervention has worked in practice and how clinicians/parents have experienced these consultations.
Guidance will be part of a diagnostic algorithm which includes clinically guided POC CRP testing and safety netting advice to inform parents on what to expect and what to look out for.
Individual interviews will be conducted with clinicians and parents taking part in the trial within 30 days after the first contact consultation, to explore the social processes influencing embedding of the intervention within practice, and behaviour change techniques.
These individual telephone interviews will be performed with a selection of parents to address whether their concerns were discussed appropriately and whether their expectations were met and how they experienced the consultation and/or POC CRP testing.
The safety-netting advice will be supported by a parent information booklet, based on previous research (the "When should I worry"-interactive booklet (a guide to Coughs, Colds, Earache \& Sore Throats), the "Mijn kind heeft koorts" booklet (Eefje de Bont, www.thuisarts.nl), and the "Caring for children with coughs"-leaflet (information about how to look after a child who has a cough and when to see the doctor)).
The findings of this study could change the practice of ambulatory care physicians and might be of great interest to parents and childcare providers. The investigators will publish the findings of this research in academic journals, present at national conferences and discuss results with groups responsible for the national guidance on how to assess acutely ill children (Domus Medica, SSMG).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- multicentre, cluster-randomized, parallel group pragmatic trial
| Arm | Type | Receives |
|---|---|---|
| Intervention: Diagnostic algorithm | Active comparator | Other: diagnostic algorithmdiagnostic algorithm including a standardised clinical assessment, a Point-of-care C-reactive protein test, and safety netting advice |
| Usual care | No intervention | –In the control arm, patients will receive 'usual care' left at the discretion of the treating physician. Apart from the general training session for all participating physicians they have attended prior to recruitment and randomization, physicians in the control arm will not receive additional tools. They are expected (but not forced) to follow the Belgian guidelines (as described in "BAPCOC National guidelines and the RIZIV consensus meeting "Rational use of antibiotics in children"). |
Who may qualify
- Ages
- 6 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Being able to recruit acutely ill children (ideally consecutively)
- Agree to the terms of the clinical study agreement.
- Children aged 6 months to 12 years, provided informed consent can be obtained
- presenting with an acute illness episode that started maximum 10 days before the index consultation
Key exclusion criteria (9 listed)
- Currently using a POC CRP device as part of their routine care
- No practices will be excluded on other grounds than the above. Age, demographics, geographic region will not be used to exclude eligible practices. This will provide us with a real-life, representative subset of ambulatory care physicians.
- Children who were previously included in this trial
- children with an underlying known chronic condition (e.g. asthma, immune deficiency)
- clinically unstable warranting immediate care
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 |
|---|---|---|
| diagnostic algorithmGuidance will be part of a diagnostic algorithm which includes clinically guided point-of-care C-reactive protein testing and safety netting advice to inform parents on what to expect and what to look out for. A selection of clinical features will be assessed and recorded by the physician in the patient's health record and on the e-CRF, including the clinical decision tree (clinician's gut feeling, body temperature, dyspnea). The safety-netting advice will be supported by a parent information booklet, based on previous research (the "When should I worry"-interactive booklet (a guide to Coughs, Colds, Earache \& Sore Throats), the "Mijn kind heeft koorts" booklet (Eefje de Bont, www.thuisarts.nl), and the "Caring for children with coughs"-leaflet (information about how to look after a child who has a cough and when to see the doctor)). | Other | Intervention: Diagnostic algorithm |
Primary outcome
Antibiotic Prescribing Rate at Index Consultation (Immediate or Delayed)
Time frame: This outcome will be registered immediately at the index consultation (immediately after the intervention)
The primary outcome is the percentage of participants who were prescribed antibiotic treatment (both immediate and delayed) at the index consultation as recorded by the treating physician.
4 secondary outcomes
Clinical Recovery During Follow-up
Time frame: This outcome will be checked from the diary (via app for parents) from first day after the intervention until day of full clinical recovery (up to maximum 30 days after after the intervention)
Additional Investigations at Index Consultation and/or During Follow-up
Time frame: This composite outcome will be registered immediately after the intervention and/or checked from the patient health record from the first day to day 30 after the intervention
Re-consultation During Follow-up
Time frame: This outcome will be checked from the patient health record from first day to day 30 after the intervention
Antibiotic Prescribing Rate During Follow-up
Time frame: This outcome will be checked from the patient health record first day to day 30 after the intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29269559Verbakel JY, Lemiengre MB, De Burghgraeve T, De Sutter A, Aertgeerts B, Bullens DMA, Shinkins B, Van den Bruel A, Buntinx F. Point-of-care C reactive protein to identify serious infection in acutely ill children presenting to hospital: prospective cohort study. Arch Dis Child. 2018 May;103(5):420-426. doi: 10.1136/archdischild-2016-312384. Epub 2017 Dec 21.
- Background: PubMed 24025452Verbakel JY, Aertgeerts B, Lemiengre M, Sutter AD, Bullens DM, Buntinx F. Analytical accuracy and user-friendliness of the Afinion point-of-care CRP test. J Clin Pathol. 2014 Jan;67(1):83-6. doi: 10.1136/jclinpath-2013-201654. Epub 2013 Sep 11. No abstract available.
- Background: PubMed 27716201Verbakel JY, Lemiengre MB, De Burghgraeve T, De Sutter A, Aertgeerts B, Shinkins B, Perera R, Mant D, Van den Bruel A, Buntinx F. Should all acutely ill children in primary care be tested with point-of-care CRP: a cluster randomised trial. BMC Med. 2016 Oct 6;14(1):131. doi: 10.1186/s12916-016-0679-2.
- Derived from this study: PubMed 41016406Verbakel JY, Burvenich R, D'hulster E, De Rop L, Van den Bruel A, Anthierens S, Coenen S, De Sutter A, Heytens S, Joly L, Digregorio M, Laenen A, Luyten J, De Burghgraeve T. A clinical decision tool including a decision tree, point-of-care testing of CRP, and safety-netting advice to guide antibiotic prescribing in acutely ill children in primary care in Belgium (ARON): a pragmatic, cluster-randomised, controlled trial. Lancet. 2025 Oct 11;406(10512):1599-1610. doi: 10.1016/S0140-6736(25)01239-5. Epub 2025 Sep 25.
- Derived from this study: PubMed 34980633Verbakel JYJ, De Burghgraeve T, Van den Bruel A, Coenen S, Anthierens S, Joly L, Laenen A, Luyten J, De Sutter A. Antibiotic prescribing rate after optimal near-patient C-reactive protein testing in acutely ill children presenting to ambulatory care (ARON project): protocol for a cluster-randomized pragmatic trial. BMJ Open. 2022 Jan 3;12(1):e058912. doi: 10.1136/bmjopen-2021-058912.
- Individual participant dataSharing planned: Yes. Individual patient data from this trial will not be published in the public domain. Deidentified participant data is available for further analyses. Requests for data, with justification, should be sent to Jan Verbakel (Jan . verbakel @ kuleuven.be, Tine De Burghgraeve (tine . deburghgraeve @ kuleuven.be. The trial protocol is available online for an indefinite period.
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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.
Jan Y Verbakel, MD, PhD principal investigator
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 diagnostic algorithm 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 9 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 23 Apr 2025. 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?
Yes. Results are posted in the registry (first posted 23 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Antibiotic Prescribing Rate at Index Consultation (Immediate or Delayed) (time frame: This outcome will be registered immediately at the index consultation (immediately after the intervention)). 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 NCT04470518, which also lists 5 linked publications.
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 23 Apr 2025.