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

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

Conditions

• Infection

Interventions

OTHER

diagnostic algorithm

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)).

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven

  collaborator OTHER

• University Ghent

  collaborator OTHER

• Universiteit Antwerpen

  collaborator OTHER

• University of Liege

  collaborator OTHER

• Vrije Universiteit Brussel

  collaborator OTHER

• Université Catholique de Louvain

  collaborator OTHER

• KU Leuven

  lead OTHER

Principal Investigators

• Jan Y Verbakel, MD, PhD · KU Leuven

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

6 Months

Max Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-01-06

Primary Completion

2024-02-01

Completion

2024-04-24

Countries

• Belgium

Study Locations