Fever
Conditions
Keywords
C-reactive protein
Brief summary
Fever is the leading reason for outpatient consultations among children aged 2 to 9 years. The main concern in fever is severe bacterial infection, particularly for younger children. History and clinical examination do not always differentiate viral infections from bacterial infection. In 20% of febrile children, no infectious focus is found after examination and additional tests are necessary. The first one is measuring C-reactive protein (CRP). The results are obtained in several hours on an outpatient basis, causing long delays before starting treatment and often requiring telephone calls or further consultations. Emergency room use is constantly increasing, generating growing tensions within healthcare facilities, yet a large number of visits are avoidable. Among children visiting the pediatric emergency room, parents reported being referred by their primary care physician in approximately 20% of cases for children aged 1 to 5 years and in 30% of cases for children under one year old. The use of capillary medical device to measure CRP in primary care could reduce this referral rate and help relieve overcrowding in emergency rooms, as well as unscheduled consultation centers and medical analysis laboratories. This would result in a streamlined care pathway, saving time for both physicians and patients, as well as reducing the cost of care for the healthcare system.
Interventions
OTHERCapillary CRP
CRP measured semi-quantitatively using ACTIM-CRP device
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Cluster randomized step wedge
Eligibility
Sex/Gender
ALL
Age
3 Months to 15 Years
Healthy volunteers
No
Inclusion criteria
* The patient must be a member or beneficiary of a health insurance plan * Children consulting primary health institutes with fever (temperature ≥ 38°C) requiring CRP testing: * Fever \> 12h in infants aged 3 to 6 months * Fever ≥ 5 days in children over 6 months of age * Fever \>12h regardless of age, and at the time of consultation, the doctor is concerned about the child's general condition, the tolerance of the fever, or doubts about a bacterial focus (e.g. suspicion of pneumopathy, appendicitis, etc.). * No severity criteria necessitating immediate hospitalization * No bacterial infection whose diagnosis is exclusively clinical or identified by other means (e.g. purulent AOM, bacterial angina identified by RDT, etc.). * Child whose parents and child have been informed about the study, and at least one parent has given consent for their child's participation in the study. * Enrolment of the child according to their capacity of discernment (for children aged 12 and over, enrolment is essential). * Child affiliated to or benefiting from a health insurance scheme
Exclusion criteria
* The subject is participating in a category 1 interventional study, or a study with drug or medical device * Premature infants under one year of age * Immunosuppression * Sunstroke * Chronic infection * Malignant pathology * Autoimmune pathology * Sickle cell disease * Child with a central catheter
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Referral rates to any facility equipped for emergency laboratory testing between conditions | Day 1 | Referral: Yes/No as reported by the physician |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Referral rates to medical biology laboratories between conditions | Day 1 | Referral: Yes/No as reported by the physician |
| Referral rates to emergency departments between conditions | Day 1 | Referral: Yes/No as reported by the physician |
| Number complementary tests between conditions | Day 1 | Total number of tests as reported by the physician |
| Type of complementary tests between conditions | Day 1 | Qualitative listing of all further tests classified as: biological (CBC, venous CRP, iono/creatininemia, liver function tests, ECBU, others) or imaging (chest X-ray, abdomino-pelvic ultrasound, urinary and renal ultrasound) as reported by the physician |
| GP satisfaction on care organization | Day 7 | 0-10 visual analog scale |
| The total duration of GP time between conditions | Day 7 | Minutes: measured as consultation time + examination time and time to inform the family |
| Parent satisfaction with the care pathway | Day 7 | 0-10 numeric scale |
| Rate of antibiotic prescription between conditions | Day 1 | Antibiotic prescription: Yes/No as reported by the physician |
| Duration of fever episode between groups | Day 7 | Days counted upon reaching 24 hours without fever |
| Cost-consequences between groups | Day 7 | euros |
| Budget impact analysis | Day 7 | euros |
Countries
France
Contacts
CONTACTChloé SIKIRDJI
PRINCIPAL_INVESTIGATORChloé SIKIRDJI
Centre Hospitalier Universitaire de Nīmes
Outcome results
None listed