Clinical trial NCT06910631: Optimizing the Care Pathway of Febrile Children Via Capillary C-reactive Protein Assay in Primary Care
Official title: Optimisation du Parcours de Soins Des Enfants fébriles Par l'Utilisation de la CRP Capillaire en Soins Primaires : Protocole d'un Essai Multicentrique randomisé
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Fever
Keywords: C-reactive protein
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2025-04-04
Enrollment: 420
Sex: ALL
Minimum age (years): 3
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Cluster randomized step wedge
Primary purpose: OTHER

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.


Eligibility criteria: 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
* Insulation
* Chronic infection
* Malignant pathology
* Autoimmune pathology
* Sickle cell disease
* Child with a central catheter

Primary outcomes:
measure: Referral rates to any facility equipped for emergency laboratory testing between conditions
timeFrame: Day 1
measure: Referral rates to any facility equipped for emergency laboratory testing between conditions
timeFrame: Day 7
Secondary outcomes:
measure: Referral rates to medical biology laboratories between conditions
timeFrame: Day 1
measure: Referral rates to medical biology laboratories between conditions
timeFrame: Day 7
measure: Referral rates to emergency departments between conditions
timeFrame: Day 1
measure: Referral rates to emergency departments between conditions
timeFrame: Day 7
measure: Number complementary tests between conditions
timeFrame: Day 1
measure: Number complementary tests between conditions
timeFrame: Day 7
measure: Type of complementary tests between conditions
timeFrame: Day 1
measure: Type of complementary tests between conditions
timeFrame: Day 7
measure: GP satisfaction on care organization
timeFrame: Day 7
measure: The total duration of GP time between conditions
timeFrame: Day 7
measure: Parent satisfaction with the care pathway
timeFrame: Day 7
measure: Rate of antibiotic prescription between conditions
timeFrame: Day 1
measure: Rate of antibiotic prescription between conditions
timeFrame: Day 7
measure: Duration of fever episode between groups
timeFrame: Day 7
measure: Cost-consequences between groups
timeFrame: Day 7
measure: Budget impact analysis
timeFrame: Day 7
Other outcomes:
Locations:
city: Bezouce
country: France
facility: MSP OLEA
city: Béziers
country: France
facility: MSP Espace Santé Servian
city: Cabestany
country: France
facility: MSPU Avicenne
city: Calvisson
country: France
facility: MSP de Calvisson
city: Caveirac
country: France
facility: MSP de Clarensac
city: Montpellier
country: France
facility: MMG de Montpellier
city: Montpellier
country: France
facility: MSP Montpellier-Cévennes
city: Narbonne
country: France
facility: MMG de Narbonne
city: Nimes
country: France
facility: CHU de Nîmes
city: Nîmes
country: France
facility: MMG de Nîmes
city: Pont-Saint-Esprit
country: France
facility: MSP de Pont Saint Esprit
city: Prades-Le-Lez
country: France
facility: MSPU Pauline Lautaud
city: Remoulins
country: France
facility: MSP Le Prisme
city: Saint Marcel sur Aude
country: France
facility: MSP Sud Minervois
city: Saint-Laurent d'Aigouze
country: France
facility: MSP Saint-Laurent d'Aigouze
city: Vergèze
country: France
facility: Mspu La Source
Study officials:
affiliation: Centre Hospitalier Universitaire de Nīmes
name: Chloé SIKIRDJI
role: PRINCIPAL_INVESTIGATOR
References: