N/A
N=6,750
Impact of Clinical Guidance & Point-of-care CRP in Children: the ARON Project
Infection
Bottom Line
View on ClinicalTrials.gov: NCT04470518 ↗Enrolled (actual)
6,750
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Antibiotic Prescribing Rate at Index Consultation (Immediate or Delayed) — 466; 817 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- diagnostic algorithm (Other)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- KU Leuven
- Primary completion
- Feb 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Antibiotic Prescribing Rate at Index Consultation (Immediate or Delayed) |
466; 817 | — |
| SECONDARY Clinical Recovery During Follow-up |
4.6; 4.7 | — |
| SECONDARY Additional Investigations at Index Consultation and/or During Follow-up |
335; 517 | — |
| SECONDARY Re-consultation During Follow-up |
770; 968 | — |
| SECONDARY Antibiotic Prescribing Rate During Follow-up |
291; 429 | — |
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 out-of-hospital community paediatrics offices
Intervention(s) Diagnostic algorithm:
1. Clinical decision tree: clinician's gut feeling something is wrong, dyspnea, temperature ≥40ºC
2. 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)
3. 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:
o Belgische Commissie voor de Coördinatie van het Antibioticabeleid (BAPCOC) guide (updated November 2019)
o 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
Eligibility Criteria
Inclusion Criteria for practices:
- Being able to recruit acutely ill children (ideally consecutively)
- Agree to the terms of the clinical study agreement.
Exclusion Criteria for practices:
- 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.
Inclusion criteria for children
- 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
Exclusion criteria for children
- 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
- trauma as the main presenting problem
- antibiotics taken in the previous 7 days
- Unwillingness or inability to provide informed consent
Data sourced from ClinicalTrials.gov (NCT04470518). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.