Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06910631

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

3 month–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre médical du Grau D'Agde, Agde, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Capillary CRP

Other

CRP measured semi-quantitatively using ACTIM-CRP device

Primary outcomes

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

    Time frame: Day 1

    Referral: Yes/No as reported by the physician

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

    Time frame: Day 7

    Referral: Yes/No as reported by the parents

Secondary outcomes

  1. Referral rates to medical biology laboratories between conditions

    Time frame: Day 1

    Referral: Yes/No as reported by the physician

  2. Referral rates to medical biology laboratories between conditions

    Time frame: Day 7

    Referral: Yes/No as reported by the parents

  3. Referral rates to emergency departments between conditions

    Time frame: Day 1

    Referral: Yes/No as reported by the physician

  4. Referral rates to emergency departments between conditions

    Time frame: Day 7

    Referral: Yes/No as reported by the parents

  5. Number complementary tests between conditions

    Time frame: Day 1

    Total number of tests as reported by the physician

  6. Number complementary tests between conditions

    Time frame: Day 7

    Total number of tests as reported by the parents

  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

  8. 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

  9. GP satisfaction on care organization

    Time frame: Day 7

    0-10 visual analog scale

  10. 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

  11. Parent satisfaction with the care pathway

    Time frame: Day 7

    0-10 numeric scale

  12. Rate of antibiotic prescription between conditions

    Time frame: Day 1

    Antibiotic prescription: Yes/No as reported by the physician

  13. Rate of antibiotic prescription between conditions

    Time frame: Day 7

    Antibiotic prescription: Yes/No as reported by the parents

  14. Duration of fever episode between groups

    Time frame: Day 7

    Days counted upon reaching 24 hours without fever

  15. Cost-consequences between groups

    Time frame: Day 7

    euros

  16. Budget impact analysis

    Time frame: Day 7

    euros

Study contacts

Contact information is provided by the study sponsor or research team.

Chloé SIKIRDJI

CONTACT

[email protected]

06.15.56.80.28

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

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

Acronym: CRP-CAP

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 4, 2025
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.