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ClinicalTrials.gov ID

NCT06910631

Lead Sponsor

Centre Hospitalier Universitaire de NīmesOTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

420Estimated

Last Update Posted

Jun 23, 2026Actual

Start Date

Sep 15, 2025Actual

Primary Completion Date

Jun 2027Estimated

Completion Date

Jun 2027Estimated

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

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.

• Fever

• Capillary CRP

Ages Eligible for Study

Child (0-17)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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
• Sunstroke
• Chronic infection
• Malignant pathology
• Autoimmune pathology
• Sickle cell disease
• Child with a central catheter

Primary Purpose

Other

Allocation

Randomized

Interventional Model

Single Group Assignment

Masking

Single

Lead Sponsor

Centre Hospitalier Universitaire de NīmesOTHER

aurelie.urena@hotmail.fr04.66.68.42.36

francois.carbonnel@umontpellier.fr04.66.68.42.36

salmoncorinne@yahoo.fr0682942497

drc@chu-nimes.fr04.66.68.42.36

alexis.vandeventer@umontpellier.fr04.66.68.42.36