ClinicalTrials.gg
RecruitingNCT06910631CRP-CAPUpdated Jun 23, 2026

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

An interventional study of Capillary CRP in Fever, sponsored by Centre Hospitalier Universitaire de Nīmes. Recruiting at 37 sites in France. Open to participants aged 3 Months to 15 Years. Per ClinicalTrials.gov, last updated 2026-06-23.

Sponsored by Centre Hospitalier Universitaire de Nīmes · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Sep 2025; still recruiting 1 year 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
420
Allocation
Randomized
Ages
3 Months to 15 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Fever

Browse trials for

Keywords

  • C-reactive protein
03

In context

Fever

438 studies on the registry are indexed under Fever; 55 are open to participants now.

This study's planned enrollment of 420 is above the median of 123 across 271 interventional studies indexed under Fever.

Browse Fever studies →

Lead sponsor

Centre Hospitalier Universitaire de Nīmes is the lead sponsor of 595 studies on the registry; 90 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Months to 15 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
  • Sunstroke
  • Chronic infection
  • Malignant pathology
  • pathology
  • Sickle cell disease
  • Child with a central catheter
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Single group
Masking
Single (Outcomes assessor)
Enrollment
420 participants (estimated)

Study arms

  • Experimental
    Capillary CRP

    Other: Capillary CRP

  • No intervention
    Control

    Prior to Capillary CRP condition

Interventions

  • OtherCapillary CRP

    CRP measured semi-quantitatively using ACTIM-CRP device

06

What researchers measure

Primary outcomes

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

    Referral: Yes/No as reported by the physician

    Time frame: Day 1

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

    Referral: Yes/No as reported by the parents

    Time frame: Day 7

Secondary outcomes

  1. Referral rates to medical biology laboratories between conditions

    Referral: Yes/No as reported by the physician

    Time frame: Day 1

  2. Referral rates to medical biology laboratories between conditions

    Referral: Yes/No as reported by the parents

    Time frame: Day 7

  3. Referral rates to emergency departments between conditions

    Referral: Yes/No as reported by the physician

    Time frame: Day 1

  4. Referral rates to emergency departments between conditions

    Referral: Yes/No as reported by the parents

    Time frame: Day 7

  5. Number complementary tests between conditions

    Total number of tests as reported by the physician

    Time frame: Day 1

  6. Number complementary tests between conditions

    Total number of tests as reported by the parents

    Time frame: Day 7

  7. Type of complementary tests between conditions

    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

    Time frame: Day 1

  8. Type of complementary tests between conditions

    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

    Time frame: Day 7

  9. GP satisfaction on care organization

    0-10 visual analog scale

    Time frame: Day 7

  10. The total duration of GP time between conditions

    Minutes: measured as consultation time + examination time and time to inform the family

    Time frame: Day 7

  11. Parent satisfaction with the care pathway

    0-10 numeric scale

    Time frame: Day 7

  12. Rate of antibiotic prescription between conditions

    Antibiotic prescription: Yes/No as reported by the physician

    Time frame: Day 1

  13. Rate of antibiotic prescription between conditions

    Antibiotic prescription: Yes/No as reported by the parents

    Time frame: Day 7

  14. Duration of fever episode between groups

    Days counted upon reaching 24 hours without fever

    Time frame: Day 7

  15. Cost-consequences between groups

    euros

    Time frame: Day 7

  16. Budget impact analysis

    euros

    Time frame: Day 7

07

Study locations

37 of 37 sites recruiting
08

References and documents

Publications

  • 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. PubMed 41638749 ↗

Individual participant data

Plan to share: Yes — All IPD that underlie results in a publication

Supporting information: Study protocol, Informed consent form, Analytic code

Time frame: Upon publication

Access criteria: The IPD will be made available to other researchers upon reasonable request to the corresponding author

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2025 (actual). Primary completion is estimated for Jun 2027, 21 months after the start.

Of 66 non-industry interventional studies with no phase under Fever, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 30. This study's planned 21 months is above that.

Counting every sponsor, half of 74 studies reached it within 16 months; a quarter within 6 and three quarters within 30.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 21, 2025
First posted
Apr 4, 2025
StartActual
Sep 15, 2025
Primary completionEst.
Jun 2027
CompletionEst.
Jun 2027
Last update
Jun 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06910631
Responsible party
Sponsor
First posted
Apr 4, 2025
Start date
Sep 15, 2025
Primary completion
Jun 2027 (estimated)
Completion
Jun 2027 (estimated)
Last update
Jun 23, 2026

Study contacts

Chloé SIKIRDJI
Contact
chloe.sikirdji@umontpellier.fr
06.15.56.80.28
Chloé SIKIRDJI
principal investigator · Centre Hospitalier Universitaire de Nīmes

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion