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| Name | Class |
|---|---|
| Universitaire Ziekenhuizen KU Leuven | OTHER |
| University Ghent | OTHER |
| Universiteit Antwerpen | OTHER |
| University of Liege |
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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:
Clinical decision tree: clinician's gut feeling something is wrong, dyspnea, temperature ≥40ºC
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)
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:
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:
During a follow-up period (day 1 to day 30):
- referral to hospital
- additional investigations (X-Ray, blood tests, urine tests, etc.)
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
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 evidence and its results so far, the ARON trial will test the impact of a diagnostic algorithm including a standardised clinical assessment, a POC CRP test, and safety netting advice.
Therefore, the investigators propose to assess the clinical and cost-effectiveness of a diagnostic algorithm which includes a decision tree, POC CRP and safety netting advice in acutely ill children aged 6 months to 12 years of age presenting to ambulatory care, on AB prescribing, referral/admission to hospital, additional testing, mortality, and patient satisfaction.
More specifically, the investigators' research question is whether this diagnostic algorithm is able to safely reduce antibiotic prescribing in acutely ill children presenting to ambulatory care.
The decision whether or not to conduct a POC CRP test will depend on the standardized clinical assessment, i.e. a validated clinical decision tree, and subsequently for low-risk children on the intention to prescribe AB.
The investigators will provide clear evidence-based guidance on how to interpret the CRP test result as outlined below.
A process evaluation will examine how clinicians use CRP testing in their practice and how parents experience these consultations.
The investigators propose a study, where children (6 months to 12 years of age) will be randomised to (a) a diagnostic algorithm with CRP testing and specific guidance on when to prescribe AB or (b) usual care. 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.
The investigators aim to recruit 7000 children and will collect data registered by the participating physician, from the child's health record and children/parents directly. The investigators will describe how the intervention has worked in practice and how clinicians/parents have experienced these consultations.
Guidance will be part of a diagnostic algorithm which includes clinically guided POC CRP testing and safety netting advice to inform parents on what to expect and what to look out for.
Individual interviews will be conducted with clinicians and parents taking part in the trial within 30 days after the first contact consultation, to explore the social processes influencing embedding of the intervention within practice, and behaviour change techniques.
These individual telephone interviews will be performed with a selection of parents to address whether their concerns were discussed appropriately and whether their expectations were met and how they experienced the consultation and/or POC CRP testing.
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)).
The findings of this study could change the practice of ambulatory care physicians and might be of great interest to parents and childcare providers. The investigators will publish the findings of this research in academic journals, present at national conferences and discuss results with groups responsible for the national guidance on how to assess acutely ill children (Domus Medica, SSMG).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention: Diagnostic algorithm | Active Comparator | diagnostic algorithm including a standardised clinical assessment, a Point-of-care C-reactive protein test, and safety netting advice |
|
| Usual care | No Intervention | 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"). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| diagnostic algorithm | Other | 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)). |
| Measure | Description | Time Frame |
|---|---|---|
| Antibiotic Prescribing Rate at Index Consultation (Immediate or Delayed) | The primary outcome is the percentage of participants who were prescribed antibiotic treatment (both immediate and delayed) at the index consultation as recorded by the treating physician. | This outcome will be registered immediately at the index consultation (immediately after the intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Recovery During Follow-up | the duration (in days) until reaching full clinical recovery | 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) |
| Additional Investigations at Index Consultation and/or During Follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Additional Testing at Index Consultation | percentage of subjects receiving additional testing (including, but not limited to (X-Ray, blood tests, urine tests) at index consultation (day 0) | This outcome will be registered immediately at the index consultation |
| Additional Testing During Follow-up |
Inclusion Criteria for practices:
Exclusion Criteria for practices:
Inclusion criteria for children
Exclusion criteria for children
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| Name | Affiliation | Role |
|---|---|---|
| Jan Y Verbakel, MD, PhD | KU Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GPs associated with KU Leuven | Leuven | 3000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29269559 | Background | Verbakel JY, Lemiengre MB, De Burghgraeve T, De Sutter A, Aertgeerts B, Bullens DMA, Shinkins B, Van den Bruel A, Buntinx F. Point-of-care C reactive protein to identify serious infection in acutely ill children presenting to hospital: prospective cohort study. Arch Dis Child. 2018 May;103(5):420-426. doi: 10.1136/archdischild-2016-312384. Epub 2017 Dec 21. | |
| 24025452 |
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Individual patient data from this trial will not be published in the public domain. Deidentified participant data is available for further analyses. Requests for data, with justification, should be sent to Jan Verbakel (Jan . verbakel @ kuleuven.be, Tine De Burghgraeve (tine . deburghgraeve @ kuleuven.be. The trial protocol is available online for an indefinite period.
Study protocol is published and accessible. SAP, CSR, ICF and analytical code will be available after publishing the results in a medical journal. Individual patient data from this trial will not be published in the public domain.
Individual patient data from this trial will not be published in the public domain. Deidentified participant data is available for further analyses. Requests for data, with justification, should be sent to JYV, TDB, or RB. The trial protocol is available online for an indefinite period.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention: Diagnostic Algorithm | diagnostic algorithm including a standardised clinical assessment, a Point-of-care C-reactive protein test, and safety netting advice 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)). |
| FG001 | 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"). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention: Diagnostic Algorithm | diagnostic algorithm including a standardised clinical assessment, a Point-of-care C-reactive protein test, and safety netting advice 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)). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Antibiotic Prescribing Rate at Index Consultation (Immediate or Delayed) | The primary outcome is the percentage of participants who were prescribed antibiotic treatment (both immediate and delayed) at the index consultation as recorded by the treating physician. | Posted | Count of Participants | Participants | This outcome will be registered immediately at the index consultation (immediately after the intervention) |
|
30 days
Admission to hospital at the index consultation + Admission to hospital day 1-30
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention: Diagnostic Algorithm | diagnostic algorithm including a standardised clinical assessment, a Point-of-care C-reactive protein test, and safety netting advice 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)). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hospitalisation | Infections and infestations | Non-systematic Assessment | hospitalisation due to infections, not caused by the intervention |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tine De Burghgraeve, PhD | Leuven Unit Health Technology Assessment Research, KU Leuven | +3216377276 | tine.deburghgraeve@kuleuven.be |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 28, 2023 | Mar 28, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 28, 2024 | Feb 28, 2025 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 16, 2020 | Feb 28, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D007239 | Infections |
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| OTHER |
| Vrije Universiteit Brussel | OTHER |
| Université Catholique de Louvain | OTHER |
multicentre, cluster-randomized, parallel group pragmatic trial
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Owing to study procedures, children, their parents and physicians will not be masked to the practices' random allocation.
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|
the percentage 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) |
| 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 |
| Re-consultation During Follow-up | percentage of subjects who re-consulted their physician during follow-up (day 1 to day 30) | This outcome will be checked from the patient health record from first day to day 30 after the intervention |
| Antibiotic Prescribing Rate During Follow-up | percentage of subjects who were prescribed antibiotic treatment during follow-up (day 1 to day 30) | This outcome will be checked from the patient health record first day to day 30 after the intervention |
percentage of subjects receiving additional testing (including, but not limited to (X-Ray, blood tests, urine tests) during follow-up (day 1 to day 30) |
| during follow-up from first day to day 30 after the intervention |
| Referral to Hospital at Day 0 | percentage of subjects referred to hospital at index consultation (day 0) | This outcome will be registered immediately at the index consultation |
| Referral to Hospital During Follow-up | percentage of subjects referred to hospital during follow-up (day 1 to day 30) | during follow-up from first day to day 30 after the intervention |
| Admission to Hospital at Day 0 | percentage of subjects admitted to hospital at index consultation (day 0) | This outcome will be registered immediately at the index consultation |
| Admission to Hospital During Follow-up | percentage of subjects admitted to hospital during follow-up (day 1 to day 30) | during follow-up from first day to day 30 after the intervention |
| Mortality at Day 0 | percentage of subjects who died at index consultation (day 0) | This outcome will be registered immediately at the index consultation |
| Mortality During Follow up | percentage of subjects who died during follow-up (day 1 to day 30) | during follow-up from first day to day 30 after the intervention |
| Clinical Recovery at Day 7 | percentage of subjects with full clinical recovery at day 7 | at day 7 after the intervention |
| Clinical Recovery at Day 30 | percentage of subjects with full clinical recovery at day 30 | at day 30 after the intervention |
| Patient's Experience Through Semi-structured Interviews | Patient's experience through semi-structured interviews with pre-defined topic guide | within 7 days after the intervention |
| Parent's Experience Through Semi-structured Interviews | Parent's experience through semi-structured interviews with pre-defined topic guide | within 7 days after the intervention |
| Physician's Experience Through Semi-structured Interviews | Physician's experience through semi-structured interviews with pre-defined topic guide | within 7 days after the intervention |
| Cost-effectiveness of the Intervention | Cost-effectiveness of the intervention: healthcare expenditures in terms of hospitalization, consultations, pharmaceuticals (reimbursed and non-reimbursed), productivity, quality of life | will be assessed retrospectively after data collection has finished (24 months of recruitment) |
| Number of Participants Whose Physician Was Non-Adherent to the Diagnostic Algorithm | clinicians could deviate from the proposed diagnostic algorithm. This outcome measure comprise the percentage of participants whose physician was non-adherent to the diagnostic algorithm. This is not a protocol violation, since deviating from the algorithm was a possibility if the physician deems this necessary. | This outcome will be registered immediately at the index consultation |
| Verbakel JY, Aertgeerts B, Lemiengre M, Sutter AD, Bullens DM, Buntinx F. Analytical accuracy and user-friendliness of the Afinion point-of-care CRP test. J Clin Pathol. 2014 Jan;67(1):83-6. doi: 10.1136/jclinpath-2013-201654. Epub 2013 Sep 11. No abstract available. |
| 27716201 | Background | Verbakel JY, Lemiengre MB, De Burghgraeve T, De Sutter A, Aertgeerts B, Shinkins B, Perera R, Mant D, Van den Bruel A, Buntinx F. Should all acutely ill children in primary care be tested with point-of-care CRP: a cluster randomised trial. BMC Med. 2016 Oct 6;14(1):131. doi: 10.1186/s12916-016-0679-2. |
| 41016406 | Derived | Verbakel JY, Burvenich R, D'hulster E, De Rop L, Van den Bruel A, Anthierens S, Coenen S, De Sutter A, Heytens S, Joly L, Digregorio M, Laenen A, Luyten J, De Burghgraeve T. A clinical decision tool including a decision tree, point-of-care testing of CRP, and safety-netting advice to guide antibiotic prescribing in acutely ill children in primary care in Belgium (ARON): a pragmatic, cluster-randomised, controlled trial. Lancet. 2025 Oct 11;406(10512):1599-1610. doi: 10.1016/S0140-6736(25)01239-5. Epub 2025 Sep 25. |
| 34980633 | Derived | Verbakel JYJ, De Burghgraeve T, Van den Bruel A, Coenen S, Anthierens S, Joly L, Laenen A, Luyten J, De Sutter A. Antibiotic prescribing rate after optimal near-patient C-reactive protein testing in acutely ill children presenting to ambulatory care (ARON project): protocol for a cluster-randomized pragmatic trial. BMJ Open. 2022 Jan 3;12(1):e058912. doi: 10.1136/bmjopen-2021-058912. |
| BG001 | 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"). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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"). |
|
|
| Secondary | Clinical Recovery During Follow-up | the duration (in days) until reaching full clinical recovery | Posted | Mean | Standard Deviation | days | 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) |
|
|
|
| Secondary | Additional Investigations at Index Consultation and/or During Follow-up | the percentage 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) | Posted | Count of Participants | Participants | 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 |
|
|
|
| Secondary | Re-consultation During Follow-up | percentage of subjects who re-consulted their physician during follow-up (day 1 to day 30) | Posted | Count of Participants | Participants | This outcome will be checked from the patient health record from first day to day 30 after the intervention |
|
|
|
| Secondary | Antibiotic Prescribing Rate During Follow-up | percentage of subjects who were prescribed antibiotic treatment during follow-up (day 1 to day 30) | Posted | Count of Participants | Participants | This outcome will be checked from the patient health record first day to day 30 after the intervention |
|
|
|
| Other Pre-specified | Additional Testing at Index Consultation | percentage of subjects receiving additional testing (including, but not limited to (X-Ray, blood tests, urine tests) at index consultation (day 0) | Posted | Count of Participants | Participants | This outcome will be registered immediately at the index consultation |
|
|
|
| Other Pre-specified | Additional Testing During Follow-up | percentage of subjects receiving additional testing (including, but not limited to (X-Ray, blood tests, urine tests) during follow-up (day 1 to day 30) | Posted | Count of Participants | Participants | during follow-up from first day to day 30 after the intervention |
|
|
|
| Other Pre-specified | Referral to Hospital at Day 0 | percentage of subjects referred to hospital at index consultation (day 0) | Posted | Count of Participants | Participants | This outcome will be registered immediately at the index consultation |
|
|
|
| Other Pre-specified | Referral to Hospital During Follow-up | percentage of subjects referred to hospital during follow-up (day 1 to day 30) | Posted | Count of Participants | Participants | during follow-up from first day to day 30 after the intervention |
|
|
|
| Other Pre-specified | Admission to Hospital at Day 0 | percentage of subjects admitted to hospital at index consultation (day 0) | Posted | Count of Participants | Participants | This outcome will be registered immediately at the index consultation |
|
|
|
| Other Pre-specified | Admission to Hospital During Follow-up | percentage of subjects admitted to hospital during follow-up (day 1 to day 30) | Posted | Count of Participants | Participants | during follow-up from first day to day 30 after the intervention |
|
|
|
| Other Pre-specified | Mortality at Day 0 | percentage of subjects who died at index consultation (day 0) | Posted | Count of Participants | Participants | This outcome will be registered immediately at the index consultation |
|
|
|
| Other Pre-specified | Mortality During Follow up | percentage of subjects who died during follow-up (day 1 to day 30) | Posted | Count of Participants | Participants | during follow-up from first day to day 30 after the intervention |
|
|
|
| Other Pre-specified | Clinical Recovery at Day 7 | percentage of subjects with full clinical recovery at day 7 | Posted | Count of Participants | Participants | at day 7 after the intervention |
|
|
|
| Other Pre-specified | Clinical Recovery at Day 30 | percentage of subjects with full clinical recovery at day 30 | Posted | Count of Participants | Participants | at day 30 after the intervention |
|
|
|
| Other Pre-specified | Patient's Experience Through Semi-structured Interviews | Patient's experience through semi-structured interviews with pre-defined topic guide | Not Posted | within 7 days after the intervention | Participants |
| Other Pre-specified | Parent's Experience Through Semi-structured Interviews | Parent's experience through semi-structured interviews with pre-defined topic guide | Not Posted | within 7 days after the intervention | Participants |
| Other Pre-specified | Physician's Experience Through Semi-structured Interviews | Physician's experience through semi-structured interviews with pre-defined topic guide | Not Posted | within 7 days after the intervention | Participants |
| Other Pre-specified | Cost-effectiveness of the Intervention | Cost-effectiveness of the intervention: healthcare expenditures in terms of hospitalization, consultations, pharmaceuticals (reimbursed and non-reimbursed), productivity, quality of life | Not Posted | will be assessed retrospectively after data collection has finished (24 months of recruitment) | Participants |
| Other Pre-specified | Number of Participants Whose Physician Was Non-Adherent to the Diagnostic Algorithm | clinicians could deviate from the proposed diagnostic algorithm. This outcome measure comprise the percentage of participants whose physician was non-adherent to the diagnostic algorithm. This is not a protocol violation, since deviating from the algorithm was a possibility if the physician deems this necessary. | missing data from 2 participants | Posted | Count of Participants | Participants | This outcome will be registered immediately at the index consultation |
|
|
|
| 0 |
| 2,988 |
| 0 |
| 2,988 |
| 32 |
| 2,988 |
| EG001 | 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"). | 0 | 3,762 | 0 | 3,762 | 64 | 3,762 |
|
Investigator may only publish the Results provided that Sponsor has duly published the main Study publication. Once the main Study publication has been duly published by the Sponsor, Investigator are entitled to publish the Results provided that Sponsor has granted its prior written approval with Principal Investigator's proposed publication.