Status:
COMPLETED
Impact of Clinical Guidance & Point-of-care CRP in Children: the ARON Project
Lead Sponsor:
KU Leuven
Collaborating Sponsors:
Universitaire Ziekenhuizen KU Leuven
University Ghent
Conditions:
Infection
Eligibility:
All Genders
6-12 years
Phase:
NA
Brief 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: Childr...
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 evide...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 24 2024
Estimated Enrollment :
6750 Patients enrolled
Trial Details
Trial ID
NCT04470518
Start Date
January 6 2021
End Date
April 24 2024
Last Update
April 23 2025
Active Locations (1)
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1
GPs associated with KU Leuven
Leuven, Belgium, 3000