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

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ClinicalTrials.gov Identifier: NCT04470518
Recruitment Status : Not yet recruiting
First Posted : July 14, 2020
Last Update Posted : January 6, 2021
Sponsor:
Collaborators:
KCE
Universitaire Ziekenhuizen Leuven
University Ghent
Universiteit Antwerpen
University of Liege
VUB
Université Catholique de Louvain
Information provided by (Responsible Party):
Jan Verbakel, KU Leuven

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: 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: 6111 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): 33 months


Condition or disease Intervention/treatment Phase
Infection Other: diagnostic algorithm Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6111 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: multicentre, cluster-randomized, parallel group pragmatic trial
Masking: None (Open Label)
Masking Description: Owing to study procedures, children, their parents and physicians will not be masked to the practices' random allocation.
Primary Purpose: Other
Official Title: Impact of a Diagnostic Algorithm on Antibiotic Prescribing Rate and Further Management of Acutely Ill Children Presenting to Ambulatory Care: Multicentre, Cluster-randomized, Parallel Group Pragmatic Trial
Estimated Study Start Date : January 6, 2021
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : June 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Active Comparator: Intervention: Diagnostic algorithm
diagnostic algorithm including a standardised clinical assessment, a Point-of-care C-reactive protein test, and safety netting advice
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, dypnoea).

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)).


No Intervention: Usual care

In the control arm, patients will receive 'usual care' left at the discretion of the treating physician.

Apart from the general training session for all participating physicians they have attended prior to recruitment and randomization, physicians in the control arm will not receive additional tools.

They are expected (but not forced) to follow the Belgian guidelines (as described in "BAPCOC National guidelines and the RIZIV consensus meeting "Rational use of antibiotics in children").




Primary Outcome Measures :
  1. antibiotic prescribing rate at index consultation (immediate or delayed) [ Time Frame: This outcome will be registered immediately at the index consultation (immediately after the intervention) ]
    The primary outcome is the proportion of subjects who were prescribed antibiotic treatment (both immediate and delayed) at the index consultation as recorded by the treating physician.


Secondary Outcome Measures :
  1. Clinical recovery during follow-up [ Time Frame: This outcome will be checked from the diary (via app for parents) from first day after the intervention until day of full clinical recovery (up to maximum 30 days after after the intervention) ]
    the duration (in days) until reaching full clinical recovery

  2. Additional investigations at index consultation and/or during follow-up [ Time Frame: This composite outcome will be registered immediately after the intervention and/or checked from the patient health record from the first day to day 30 after the intervention ]
    - the proportion of subjects receiving additional testing (including, but not limited to (X-Ray, blood tests, urine tests) at index consultation (day 0) and/or during follow-up (day 1 to day 30)

  3. Re-consultation during follow-up [ Time Frame: This outcome will be checked from the patient health record from first day to day 30 after the intervention ]
    - the proportion of subjects who re-consulted their physician during follow-up (day 1 to day 30)

  4. Antibiotic prescribing rate during follow-up [ Time Frame: This outcome will be checked from the patient health record first day to day 30 after the intervention ]
    - the proportion of subjects who were prescribed antibiotic treatment during follow-up (day 1 to day 30)


Other Outcome Measures:
  1. additional testing at index consultation [ Time Frame: immediately after the intervention ]
    the proportion of subjects receiving additional testing (including, but not limited to (X-Ray, blood tests, urine tests) at index consultation (day 0)

  2. additional testing during follow-up [ Time Frame: during follow-up from first day to day 30 after the intervention ]
    the proportion of subjects receiving additional testing (including, but not limited to (X-Ray, blood tests, urine tests) during follow-up (day 1 to day 30)

  3. referral to hospital at day 0 [ Time Frame: immediately after the intervention ]
    the proportion of subjects referred to hospital at index consultation (day 0)

  4. referral to hospital during follow-up [ Time Frame: during follow-up from first day to day 30 after the intervention ]
    the proportion of subjects referred to hospital during follow-up (day 1 to day 30)

  5. admission to hospital at day 0 [ Time Frame: immediately after the intervention ]
    the proportion of subjects admitted to hospital at index consultation (day 0)

  6. admission to hospital during follow-up [ Time Frame: during follow-up from first day to day 30 after the intervention ]
    the proportion of subjects admitted to hospital during follow-up (day 1 to day 30)

  7. mortality at day 0 [ Time Frame: immediately after the intervention ]
    the proportion of subjects who died at index consultation (day 0)

  8. mortality during follow up [ Time Frame: during follow-up from first day to day 30 after the intervention ]
    the proportion of subjects who died during follow-up (day 1 to day 30)

  9. clinical recovery at day 7 [ Time Frame: at day 7 after the intervention ]
    the proportion of subjects with full clinical recovery at day 7

  10. clinical recovery at day 30 [ Time Frame: at day 30 after the intervention ]
    the proportion of subjects with full clinical recovery at day 30

  11. patient's experience through semi-structured interviews [ Time Frame: within 7 days after the intervention ]
    Patient's experience through semi-structured interviews with pre-defined topic guide

  12. Parent's experience through semi-structured interviews [ Time Frame: within 7 days after the intervention ]
    Parent's experience through semi-structured interviews with pre-defined topic guide

  13. Physician's experience through semi-structured interviews [ Time Frame: within 7 days after the intervention ]
    Physician's experience through semi-structured interviews with pre-defined topic guide

  14. Cost-effectiveness of the intervention [ Time Frame: will be assessed retrospectively after data collection has finished (24 months of recruitment) ]
    Cost-effectiveness of the intervention: healthcare expenditures in terms of hospitalization, consultations, pharmaceuticals (reimbursed and non-reimbursed), productivity, quality of life

  15. Adherence to the diagnostic algorithm [ Time Frame: immediately after the intervention ]
    proportion of consultation in which the physician did not adhere to the diagnostic algorithm



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Months to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04470518


Contacts
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Contact: Tine De Burghgraeve, PhD +3216 37 76 72 tine.deburghgraeve@kuleuven.be

Sponsors and Collaborators
KU Leuven
KCE
Universitaire Ziekenhuizen Leuven
University Ghent
Universiteit Antwerpen
University of Liege
VUB
Université Catholique de Louvain
Investigators
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Principal Investigator: Jan Y Verbakel, MD, PhD KU Leuven
Publications:
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Responsible Party: Jan Verbakel, Professor Doctor, KU Leuven
ClinicalTrials.gov Identifier: NCT04470518    
Other Study ID Numbers: S62005
First Posted: July 14, 2020    Key Record Dates
Last Update Posted: January 6, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jan Verbakel, KU Leuven:
antibiotic prescription
infections
decision tree
point-of-care C-reactive protein test
safetynet advice
Additional relevant MeSH terms:
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Infection