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Recruiting Not applicable

Optimizing the Care Pathway of Febrile Children Via Capillary C-reactive Protein Assay in Primary Care

NCT06910631 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2025-09-15
Last updated
2026-06-23

Condition(s) studied

Fever

Investigational drug(s) / intervention(s)

Capillary CRP

Capillary CRP: CRP measured semi-quantitatively using ACTIM-CRP device

Study 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

Sex
ALL
Min age
3 Months
Max age
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

Primary outcome measure(s)

  • Referral rates to any facility equipped for emergency laboratory testing between conditions — Day 1
    Referral: Yes/No as reported by the physician
  • Referral rates to any facility equipped for emergency laboratory testing between conditions — Day 7
    Referral: Yes/No as reported by the parents

Trial sites (37)

FacilityCityRegionStatus
Centre médical du Grau D'Agde Agde France Recruiting
Cabinet Medical Baho Baho France Recruiting
MSP OLEA Bezouce France Recruiting
Msp Balmat Sante Béziers France Recruiting
MSP Espace Santé Servian Béziers France Recruiting
Msp Madeleine Bres Bouillargues France Recruiting
MSP Terre de Béliers Bouillargues France Recruiting
MSPU Avicenne Cabestany France Recruiting
MSP de Calvisson Calvisson France Recruiting
MSP de Clarensac Caveirac France Recruiting
Msp Au Fil de L'Hers Deyme France Recruiting
Msp Gigean Gigean France Recruiting
Cds de Ma Region Le Vigan France Recruiting
Msp Le Cube Montgiscard France Recruiting
MMG de Montpellier Montpellier France Recruiting
Msp La Mosson Montpellier France Recruiting
MSP Montpellier-Cévennes Montpellier France Recruiting
MMG de Narbonne Narbonne France Recruiting
Msp Narbo-Ouest Narbonne France Recruiting
CHU de Nîmes Nîmes France Recruiting
MMG de Nîmes Nîmes France Recruiting
MSP Charles GIDE Nîmes France Recruiting
CABINET MEDICAL Perpignan Perpignan France Recruiting
CABINET médical de l'Étang de l'Or Pérols France Recruiting
Mspu Pins Justaret Pins-Justaret France Recruiting
MSP de Pont Saint Esprit Pont-Saint-Esprit France Recruiting
MSPU Pauline Lautaud Prades-le-Lez France Recruiting
MSP Le Prisme Remoulins France Recruiting
Msp Du Thaurac Saint-Bauzille-de-Putois France Recruiting
CABINET MEDICAL Saint-Hippolyte-du-Fort Saint-Hippolyte-du-Fort France Recruiting
Msp Saint Jean-Du Gard Saint-Jean-du-Gard France Recruiting
MSP Saint-Laurent d'Aigouze Saint-Laurent-d'Aigouze France Recruiting
MSP Sud Minervois Saint-Marcel-sur-Aude France Recruiting
CDS Filieris Saint Martin de Valgalgues Saint-Martin-de-Valgalgues France Recruiting
Maison de santé de St Quentin la Poterie Saint-Quentin-la-Poterie France Recruiting
MSP Pezenas Tourbes Tourbes France Recruiting
Mspu La Source Vergèze France Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06910631 on ClinicalTrials.gov ↗ ← All trials in France