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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
420

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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 Nîmes
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Nīmes

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 21, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 4, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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