CompletedNot Applicable

Impact of Clinical Guidance & Point-of-care CRP in Children: the ARON Project

Belgium6,750 participantsStarted 2021-01-06

Plain-language 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

Who can participate

Age range

6 Months – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Antibiotic Prescribing Rate at Index Consultation (Immediate or Delayed)

Timeframe: This outcome will be registered immediately at the index consultation (immediately after the intervention)

Trial details

NCT IDNCT04470518

SponsorKU Leuven

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-02-01

Results submitted2025-02-28

View on ClinicalTrials.gov More Infection trials