Point-of-care fingertip CRP testing to guide care for febrile children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.