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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

420 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-15

Study Completion Date

2026-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Fever

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Cluster randomized step wedge

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Capillary CRP

Group Type EXPERIMENTAL

Capillary CRP

Intervention Type OTHER

CRP measured semi-quantitatively using ACTIM-CRP device

Control

Prior to Capillary CRP condition

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Capillary CRP

CRP measured semi-quantitatively using ACTIM-CRP device

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

3 Months

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No