Optimising Diagnosis and Antibiotic Prescribing for Acutely Ill Children in Primary Care (ERNIE2)
Sepsis, Bacteraemia, Meningitis
About this trial
This is an interventional diagnostic trial for Sepsis
Eligibility Criteria
Inclusion Criteria:
- Patients aged 1 month to 16 years with an acute illness for a maximum of 5 days are included consecutively.
Exclusion Criteria:
- Children are excluded if the acute episode was caused by a merely traumatic or neurological illness, intoxication, psychiatric or behavioural problem without somatic cause, or an exacerbation of a known chronic condition. If a physician includes children twice in the study within 5 days, the second registration is considered a repeated measurement on the same subject and is subsequently excluded from the analysis.
Sites / Locations
- Universitaire Ziekenhuizen Gent
- Universitaire Ziekenhuizen Leuven
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Other
Active Comparator
Active Comparator
Active Comparator
usual care
Use of C-reactive protein point of care (CRP POC) test
Brief intervention and parent leaflet
CRP POC test and brief intervention & parent leaflet
CRP analysis will be performed during the consultation in accordance with the manufacturer's instructions. The CRP point of care test will be performed in case of a positive decision tree (irrespective of the intervention group) and also in case of a negative decision tree by clinicians of intervention group 1 and 2. Because no reliable cut-off points for CRP are known currently (as this is the aim of this study) for acute infections in children in primary care (nor for referral, nor for prescription of antibiotics), clinicians will not be given guidance on the interpretation of the CRP results. We will not impose restrictions on the clinicians about treatment, other technical investigations nor referrals. The device distributor will provide technical assistance. All clinicians will be trained in the use of the CRP device prior to the start of the study.
Combination of CRP POC test and the brief intervention & parent information leaflet intervention groups (factorial design)