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

NCT06910631 | Recruiting

• 1 other identifier: RESPIR/2023/CS-01
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 16

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.

Conditions

Fever

Keywords

C-reactive protein

Outcome Measures

Primary Outcomes (2)

• Referral rates to any facility equipped for emergency laboratory testing between conditions

  Referral: Yes/No as reported by the physician

  Day 1

• Referral rates to any facility equipped for emergency laboratory testing between conditions

  Referral: Yes/No as reported by the parents

  Day 7

Secondary Outcomes (16)

• Referral rates to medical biology laboratories between conditions

  Day 1

• Referral rates to medical biology laboratories between conditions

  Day 7

• Referral rates to emergency departments between conditions

  Day 1

• Referral rates to emergency departments between conditions

  Day 7

• Number complementary tests between conditions

  Day 1

Study Arms (2)

Capillary CRP

EXPERIMENTAL

Other: Capillary CRP

Control

NO INTERVENTION

Prior to Capillary CRP condition

Interventions

Capillary CRP OTHER

CRP measured semi-quantitatively using ACTIM-CRP device

Capillary CRP

Eligibility Criteria

• Age: 3 Months - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (16)

MSP OLEA

Bezouce, France

RECRUITING

MSP Espace Santé Servian

Béziers, France

RECRUITING

MSPU Avicenne

Cabestany, France

RECRUITING

MSP de Calvisson

Calvisson, France

RECRUITING

MSP de Clarensac

Caveirac, France

RECRUITING

MMG de Montpellier

Montpellier, France

RECRUITING

MSP Montpellier-Cévennes

Montpellier, France

RECRUITING

MMG de Narbonne

Narbonne, France

RECRUITING

CHU de Nîmes

Nîmes, France

RECRUITING

MMG de Nîmes

Nîmes, France

RECRUITING

MSP de Pont Saint Esprit

Pont-Saint-Esprit, France

RECRUITING

MSPU Pauline Lautaud

Prades-le-Lez, France

RECRUITING

MSP Le Prisme

Remoulins, France

RECRUITING

MSP Saint-Laurent d'Aigouze

Saint-Laurent-d'Aigouze, France

RECRUITING

MSP Sud Minervois

Saint-Marcel-sur-Aude, France

RECRUITING

Mspu La Source

Vergèze, France

RECRUITING

Related Publications (1)

• Griffiths K, Badin M, Bouvet S, Silvente L, Demattei C, Sikirdji C. 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. BMJ Open. 2026 Feb 4;16(2):e109414. doi: 10.1136/bmjopen-2025-109414.

  PMID: 41638749 DERIVED

MeSH Terms

Conditions

Fever

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Chloé SIKIRDJI

  Centre Hospitalier Universitaire de Nīmes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chloé SIKIRDJI

CONTACT

06.15.56.80.28; chloe.sikirdji@umontpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster randomized step wedge

Study Record Dates

• First Submitted: March 21, 2025
• First Posted: April 4, 2025
• Study Start: September 15, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: Upon publication
• Access Criteria: The IPD will be made available to other researchers upon reasonable request to the corresponding author

Locations

FR (16)