KCE-181137: Impact of clinical guidance & point-of-care CRP in children: the ARON project

Summary (French or Dutch)

Children become ill quite often, mainly caused by infections, most of which can be managed safely in the community without the need for antibiotics. However, many children are prescribed antibiotics which contributes to antimicrobial resistance and reinforces health-seeking behaviour. General practitioners (GP) often cite diagnostic uncertainty as a reason to prescribe antibiotics. We aim to strengthen the assessment of acutely ill children in primary care, by introducing an evidence-based diagnostic algorithm that can help GPs decide when to withhold antibiotic treatment. A recent review of the literature showed that using C-reactive protein (CRP) as a point-of-care test i.e. performed in the GP surgery reduces antibiotic prescriptions up to 44% in children if guidance is provided. We interviewed parents and clinicians who took part in a study on point-of-care CRP and found general support for the test but the doctors wanted specific guidance on how to deal with the test result. We propose a study, where children (6 month to 12 years of age) will be randomised to (a) a diagnostic algorithm with CRP testing, safety netting and specific guidance on when to prescribe antibiotics or (b) usual care, alongside the existing evidence-based antibiotic prescribing guidelines. 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. We aim to recruit 6111 children and will collect data from the child's medical record and parents directly. We will describe how the intervention has worked in practice and how clinicians/parents have experienced these consultations. The findings of this study could change the practice of GPs and might be of great interest to parents and childcare providers.

Trial Description
Title Impact of a diagnostic algorithm including clinically guided point-of-care C-reactive protein testing and safety netting advice on antibiotic prescribing rate and further management of acutely ill children presenting to ambulatory care: multicentre, cluster-randomized, parallel group pragmatic trial

Participants (P)

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 (I)

Diagnostic algorithm including a point of care CRP test

Control (C)

Diagnosis and Treatment/Management as per usual care

Outcome (O)

Antibiotic prescribing rate at index consultation

Trial Design

Multicentre, cluster-randomized, parallel group pragmatic trial

Sample Size

122 GPs including 6111 children

Trial duration

33 months from FPI to CSR

Budget

€2,980,000

Status

Open

 

Trial team

Sponsor

UZ Leuven

Chief Investigator

Prof Dr Jan Y Verbakel

Participating Investigators

Academic centres for general practice of KU Leuven, U Liege, U Gent, VUB, U Antwerp, UC Louvain

Lead Dutch speaking GPs

Prof Dr An De Sutter

Lead French speaking GPs

Prof Dr Marc Vanmeerbeek

External partner

Abbott Rapid Diagnostics BV

Documents
Protocol  
Report

Q2/2023

Publication

 

References
Funding scheme

2018 Investigator led