Optimizing the Care Pathway of Febrile Children Via Capillary C-reactive Protein Assay in Primary… (NCT06910631) | Clinical Trial Compass
RecruitingNot Applicable
Optimizing the Care Pathway of Febrile Children Via Capillary C-reactive Protein Assay in Primary Care
France420 participantsStarted 2025-09-15
Plain-language 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.
Who can participate
Age range
3 Months – 15 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Referral rates to any facility equipped for emergency laboratory testing between conditions
Timeframe: Day 1
2
Referral rates to any facility equipped for emergency laboratory testing between conditions