Point-of-care fingertip CRP testing to guide care for febrile children
Optimisation du Parcours de Soins Des Enfants fébriles Par l'Utilisation de la CRP Capillaire en Soins Primaires : Protocole d'un Essai Multicentrique randomisé
We will test a small fingertip (capillary) C‑reactive protein (CRP) test in primary care to help doctors decide care for children with fever who need a CRP measurement.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 420 (estimated) |
| Ages | 3 Months to 15 Years |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Nīmes Academic / other |
| Locations | 16 sites (Bezouce and 15 other locations) |
| Trial ID | NCT06910631 on ClinicalTrials.gov |
What this trial studies
Primary care clinicians will perform a capillary CRP assay during the consultation to obtain immediate CRP results rather than sending blood to an external laboratory. Children who present with fever, meet the study's duration and clinical criteria, and do not require immediate hospitalization will be enrolled with parental consent. The on-the-spot CRP result is intended to help distinguish likely viral illness from possible bacterial infection, reduce unnecessary emergency referrals, and shorten delays before starting appropriate treatment. Study outcomes will include effects on clinical decision-making, referral and emergency room use, and workflow in participating primary care sites.
Who should consider this trial
Good fit: Children presenting to participating primary care clinics with fever (≥38°C) who meet the study's duration and clinical criteria, have no immediate severity signs, and whose parent(s) provide consent.
Not a fit: Children with bacterial infections already diagnosed clinically or by other rapid tests, or those requiring immediate hospitalization, are unlikely to benefit from point‑of‑care capillary CRP in this protocol.
Why it matters
Potential benefit: If successful, this approach could provide quicker test results at the clinic, reduce unnecessary emergency visits, and speed appropriate treatment for febrile children.
How similar studies have performed: Previous point‑of‑care CRP studies—mostly in adults and some pediatric settings—have reduced unnecessary antibiotic prescribing and referrals, but results vary by setting and protocol.
Eligibility criteria
Show full inclusion / exclusion 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 * Sunstroke * Chronic infection * Malignant pathology * Autoimmune pathology * Sickle cell disease * Child with a central catheter
Where this trial is running
Bezouce and 15 other locations
- Msp Olea — Bezouce, France (Recruiting)
- MSP Espace Santé Servian — Béziers, France (Recruiting)
- MSPU Avicenne — Cabestany, France (Recruiting)
- MSP de Calvisson — Calvisson, France (Recruiting)
- MSP de Clarensac — Caveirac, France (Recruiting)
- MMG de Montpellier — Montpellier, France (Recruiting)
- MSP Montpellier-Cévennes — Montpellier, France (Recruiting)
- MMG de Narbonne — Narbonne, France (Recruiting)
- CHU de Nîmes — Nîmes, France (Recruiting)
- MMG de Nîmes — Nîmes, 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 Saint-Laurent d'Aigouze — Saint-Laurent-d'Aigouze, France (Recruiting)
- MSP Sud Minervois — Saint-Marcel-sur-Aude, France (Recruiting)
- Mspu La Source — Vergèze, France (Recruiting)
Study contacts
- Principal investigator: Chloé SIKIRDJI — Centre Hospitalier Universitaire de Nīmes
- Study coordinator: Chloé SIKIRDJI
- Email: chloe.sikirdji@umontpellier.fr
- Phone: 06.15.56.80.28
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.