Actively Recruiting

Phase Not Applicable
Age: 3Months - 15Years
All Genders
ID06910631

Optimizing the Care Pathway of Febrile Children Using Capillary C-reactive Protein Measurement in Primary Care: A Multicenter Randomized Trial Protocol

Led by Centre Hospitalier Universitaire de Nīmes · Updated on 2025-11-19

420

Participants Needed

16

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating how using a capillary medical device to measure C-reactive protein (CRP) in primary care can improve the care pathway for children aged 3 months to 15 years who have fever. Fever is a common reason for outpatient visits in children aged 2 to 9 years, and distinguishing between viral and bacterial infections is challenging. The study aims to reduce unnecessary referrals to emergency rooms and laboratories, which can cause overcrowding and delays in treatment, by providing quicker CRP results in primary care settings. The study compares two groups: one where CRP is measured using a capillary device called ACTIM-CRP during primary care visits, and a control group receiving usual care without this device. Children with fever meeting specific criteria related to duration and severity are included. The trial is randomized and single-blinded, starting in September 2025 and continuing until March 2026. Researchers will observe how the use of capillary CRP affects referrals to emergency facilities and laboratory testing at days 1 and 7 after consultation. Participants will be assessed for referral rates to emergency laboratories and departments, the number and type of additional tests, antibiotic prescriptions, fever duration, and satisfaction of both general practitioners and parents. Researchers will also analyze the time general practitioners spend and the cost impact of care. Data will be collected at baseline and follow-up visits, with careful monitoring of outcomes over seven days. The study is sponsored by Centre Hospitalier Universitaire de Nîmes and aims to streamline fever management in children, potentially reducing healthcare strain and costs.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 3Months - 15Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • The child must be a member or beneficiary of a health insurance plan
  • Children aged 3 months to 15 years consulting primary care with fever (temperature ≥ 38°C) requiring CRP testing
  • Fever over 12 hours in infants aged 3 to 6 months
  • Fever lasting 5 days or more in children over 6 months
  • Fever over 12 hours at consultation with concerns about general condition or possible bacterial focus
  • No severity signs requiring immediate hospitalization
  • No bacterial infection diagnosed clinically or by other means
  • Parents and child (if aged 12 or older) must be informed and consent to participation
  • Enrollment according to the child's capacity of discernment for those 12 and over
Not Eligible

You will not qualify if you...

  • Participation in another category 1 interventional study or study involving drugs or medical devices
  • Premature infants under one year of age
  • Immunosuppression
  • Sunstroke
  • Chronic infection
  • Malignant pathology
  • Autoimmune pathology
  • Sickle cell disease
  • Child with a central catheter

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Day 1

Participants undergo capillary CRP measurement during their primary care consultation to guide clinical decisions.

1 visit (in-person)

Follow-up

Duration - 7 days

Participants are followed up to assess referral rates, antibiotic prescriptions, fever duration, and satisfaction with care.

1 follow-up visit (in-person or remote)

Trial Site Locations

Total: 16 locations

1

MSP OLEA

Bezouce, France

Actively Recruiting

2

MSP Espace Santé Servian

Béziers, France

Actively Recruiting

3

MSPU Avicenne

Cabestany, France

Actively Recruiting

4

MSP de Calvisson

Calvisson, France

Actively Recruiting

5

MSP de Clarensac

Caveirac, France

Actively Recruiting

6

MMG de Montpellier

Montpellier, France

Actively Recruiting

7

MSP Montpellier-Cévennes

Montpellier, France

Actively Recruiting

8

MMG de Narbonne

Narbonne, France

Actively Recruiting

9

CHU de Nîmes

Nîmes, France

Actively Recruiting

10

MMG de Nîmes

Nîmes, France

Actively Recruiting

11

MSP de Pont Saint Esprit

Pont-Saint-Esprit, France

Actively Recruiting

12

MSPU Pauline Lautaud

Prades-le-Lez, France

Actively Recruiting

13

MSP Le Prisme

Remoulins, France

Actively Recruiting

14

MSP Saint-Laurent d'Aigouze

Saint-Laurent-d'Aigouze, France

Actively Recruiting

15

MSP Sud Minervois

Saint-Marcel-sur-Aude, France

Actively Recruiting

16

Mspu La Source

Vergèze, France

Actively Recruiting

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Research Team

C

Chloé SIKIRDJI

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

2

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Published Research Related To This Trial

Optimising the care pathway of febrile children via capillary C-reactive protein assay in primary care: the CRP-CAP cluster randomised stepped-wedge study protocol.

Karolina Griffiths, Mélanie Badin, Sophie Bouvet...

https://pubmed.ncbi.nlm.nih.gov/41638749