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NCT06910631 | NOT YET RECRUITING | Fever

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

Nīmes University Hospital Center

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.

Condition or disease

Fever

Intervention/treatment

Capillary CRP

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 420 participants
Masking : SINGLE
Primary Purpose : OTHER
Official Title : Optimization of the care path of febrile children by the use of the hair CRP in primary care: Protocol of a multicenter randomized randomized trial
Actual Study Start Date : 2025-09
Estimated Primary Completion Date : 2026-03
Estimated Study Completion Date : 2026-03

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 3 Months to 15 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Optimizing the Care Pathway of Febrile Children Via Capillary C-reactive Protein Assay in Primary Care

Location Details

NCT06910631

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How to Participate

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Locations

Not yet recruiting

France,

MSP OLEA

Bezouce, France,

Not yet recruiting

France,

MSP Espace Santé Servian

Béziers, France,

Not yet recruiting

France,

MSPU Avicenne

Cabestany, France,

Not yet recruiting

France,

MSP of Calvison

Calvisson, France,

Not yet recruiting

France,

MSP of Clarensac

Skull, France,

Not yet recruiting

France,

Mmg the montpellier

Montpellier, France,

Not yet recruiting

France,

MSP Montpellier-Cévennes

Montpellier, France,

Not yet recruiting

France,

MMG of Narbonne

Narbonne, France,

Not yet recruiting

France,

Chu de nîmes

In the name, France,

Not yet recruiting

France,

MMG of Nîmes

Nîmes, France,

Not yet recruiting

France,

MSP de Pont Saint Esprit

Pont-Saint-Esprit, France,

Not yet recruiting

France,

Mspa Puline Laked

Prades-le-Lez, France,

Not yet recruiting

France,

MSP prism

Remoulins, France,

Not yet recruiting

France,

MSP Sud Minervois

Saint Marcel on Aude, France,

Not yet recruiting

France,

MSP Saint-Laurent d'Aigouze

Saint-Laurent d'Aigouze, France,

Not yet recruiting

France,

SOURCE MSPU

Ashamed of, France,