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

June 19, 2026 updated by: Centre Hospitalier Universitaire de Nīmes

Optimisation du Parcours de Soins Des Enfants fébriles Par l'Utilisation de la CRP Capillaire en Soins Primaires : Protocole d'un Essai Multicentrique randomisé

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

420

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Agde, France
        • Recruiting
        • Centre médical du Grau D'Agde
        • Contact:
      • Baho, France
        • Recruiting
        • Cabinet Medical Baho
        • Contact:
      • Bezouce, France
      • Bouillargues, France
        • Recruiting
        • Msp Madeleine Bres
        • Contact:
      • Bouillargues, France
      • Béziers, France
      • Béziers, France
      • Cabestany, France
      • Calvisson, France
      • Caveirac, France
        • Recruiting
        • MSP de Clarensac
        • Contact:
      • Deyme, France
      • Gigean, France
      • Le Vigan, France
      • Montgiscard, France
      • Montpellier, France
      • Montpellier, France
      • Montpellier, France
        • Recruiting
        • Msp La Mosson
        • Contact:
      • Narbonne, France
        • Recruiting
        • MMG de Narbonne
        • Contact:
      • Narbonne, France
        • Recruiting
        • Msp Narbo-Ouest
        • Contact:
      • Nîmes, France
        • Recruiting
        • Chu de Nimes
        • Contact:
      • Nîmes, France
      • Nîmes, France
      • Perpignan, France
      • Pins-Justaret, France
      • Pont-Saint-Esprit, France
        • Recruiting
        • MSP de Pont Saint Esprit
        • Contact:
      • Prades-le-Lez, France
      • Pérols, France
      • Remoulins, France
      • Saint-Bauzille-de-Putois, France
      • Saint-Hippolyte-du-Fort, France
      • Saint-Jean-du-Gard, France
        • Recruiting
        • Msp Saint Jean-Du Gard
        • Contact:
      • Saint-Laurent-d'Aigouze, France
      • Saint-Marcel-sur-Aude, France
        • Recruiting
        • MSP Sud Minervois
        • Contact:
      • Saint-Martin-de-Valgalgues, France
        • Recruiting
        • CDS Filieris Saint Martin de Valgalgues
        • Contact:
      • Saint-Quentin-la-Poterie, France
        • Recruiting
        • Maison de santé de St Quentin la Poterie
        • Contact:
      • Tourbes, France
      • Vergèze, France

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Capillary CRP
Other: Capillary CRP
CRP measured semi-quantitatively using ACTIM-CRP device
No Intervention: Control
Prior to Capillary CRP condition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Referral rates to any facility equipped for emergency laboratory testing between conditions
Time Frame: Day 1
Referral: Yes/No as reported by the physician
Day 1
Referral rates to any facility equipped for emergency laboratory testing between conditions
Time Frame: Day 7
Referral: Yes/No as reported by the parents
Day 7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Referral rates to medical biology laboratories between conditions
Time Frame: Day 1
Referral: Yes/No as reported by the physician
Day 1
Referral rates to medical biology laboratories between conditions
Time Frame: Day 7
Referral: Yes/No as reported by the parents
Day 7
Referral rates to emergency departments between conditions
Time Frame: Day 1
Referral: Yes/No as reported by the physician
Day 1
Referral rates to emergency departments between conditions
Time Frame: Day 7
Referral: Yes/No as reported by the parents
Day 7
Number complementary tests between conditions
Time Frame: Day 1
Total number of tests as reported by the physician
Day 1
Number complementary tests between conditions
Time Frame: Day 7
Total number of tests as reported by the parents
Day 7
Type of complementary tests between conditions
Time Frame: Day 1
Qualitative listing of all further tests classified as: biological (CBC, venous CRP, iono/creatininemia, liver function tests, ECBU, others) or imaging (chest X-ray, abdomino-pelvic ultrasound, urinary and renal ultrasound) as reported by the physician
Day 1
Type of complementary tests between conditions
Time Frame: Day 7
Qualitative listing of all further tests classified as: biological (CBC, venous CRP, iono/creatininemia, liver function tests, ECBU, others) or imaging (chest X-ray, abdomino-pelvic ultrasound, urinary and renal ultrasound) as reported by the parents
Day 7
GP satisfaction on care organization
Time Frame: Day 7
0-10 visual analog scale
Day 7
The total duration of GP time between conditions
Time Frame: Day 7
Minutes: measured as consultation time + examination time and time to inform the family
Day 7
Parent satisfaction with the care pathway
Time Frame: Day 7
0-10 numeric scale
Day 7
Rate of antibiotic prescription between conditions
Time Frame: Day 1
Antibiotic prescription: Yes/No as reported by the physician
Day 1
Rate of antibiotic prescription between conditions
Time Frame: Day 7
Antibiotic prescription: Yes/No as reported by the parents
Day 7
Duration of fever episode between groups
Time Frame: Day 7
Days counted upon reaching 24 hours without fever
Day 7
Cost-consequences between groups
Time Frame: Day 7
euros
Day 7
Budget impact analysis
Time Frame: Day 7
euros
Day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nīmes

Investigators

  • Principal Investigator: Chloé SIKIRDJI, Centre Hospitalier Universitaire de Nîmes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

March 21, 2025

First Submitted That Met QC Criteria

March 27, 2025

First Posted (Actual)

April 4, 2025

Study Record Updates

Last Update Posted (Actual)

June 23, 2026

Last Update Submitted That Met QC Criteria

June 19, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RESPIR/2023/CS-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD that underlie results in a publication

IPD Sharing Time Frame

Upon publication

IPD Sharing Access Criteria

The IPD will be made available to other researchers upon reasonable request to the corresponding author

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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