FeverCRP-CAPNCT06910631
Optimizing the Care Pathway of Febrile Children Via Capillary C-reactive Protein Assay in Primary Care
A study testing Capillary CRP in people with Fever, run by Centre Hospitalier Universitaire de Nīmes at 37 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 months to 15 years
- Conditions the study is for
- Fever
- What is being tested?
- Capillary CRP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 37 sitesFrance
- Study dates
- 15 Sep 2025to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 9Show fewer
- Autoimmune pathology
- Sickle cell disease
- Child with a central catheter
Trial locations and contacts
37 sites in 1 country. Contact the study team or a site near you to ask about taking part.
37 sites in 1 country
France37 sites, 37 recruiting
- Recruiting
Centre médical du Grau D'Agde
Agde
Brahm DELAPORTE, 06 31 69 48 80, brahm.delaporte@gmail.com
- Recruiting
Cabinet Medical Baho
Baho
Pamela RODRIGUEZ, 0423324161, pamero1977@gmail.com
- Recruiting
Msp Balmat Sante
Béziers
Jérôme CAMPAGNAC, 0615416914, jerome.campagnac@umontpellier.fr
- Recruiting
MSP Espace Santé Servian
Béziers
Jerome Campagnac, 04.66.68.42.36, jerome.campagnac@umontpellier.fr
- Recruiting
MSP OLEA
Bezouce
Aurelie Urena, 04.66.68.42.36, aurelie.urena@hotmail.fr
- Recruiting
Msp Madeleine Bres
Bouillargues
Chantal MONTLAHUC-MARTIN, 0679339151, chan.martin@wanadoo.fr
- Recruiting
MSP Terre de Béliers
Bouillargues
Anne Sophie VINCENT, 07.71.78.61.39, docteurlape-luche30127@gmail.com
- Recruiting
MSPU Avicenne
Cabestany
Francois Carbonnel, 04.66.68.42.36, francois.carbonnel@umontpellier.fr
- Recruiting
MSP de Calvisson
Calvisson
Cécile CANDELA, 04.66.68.42.36, docteurcandela@gmail.com
- Recruiting
MSP de Clarensac
Caveirac
Marie Demey, 04.66.68.42.36, marie.demey@yahoo.fr
- Recruiting
Msp Au Fil de L'Hers
Deyme
Vladimir DRUEL, 0678664125, vladimir.druel@dumg-toulouse.fr
- Recruiting
Msp Gigean
Gigean
Corinne SALMON, 0682942497, salmoncorinne@yahoo.fr
- Recruiting
Cds de Ma Region
Le Vigan
Bénédicte GAL, 0625943778, benedicte.gal@umontpellier.fr
- Recruiting
Msp Le Cube
Montgiscard
Doriane DANIEL-BLANES, 0625840294, docteurdanieldo-riane@gmail.com
- Recruiting
MMG de Montpellier
Montpellier
Beatrice Lognos, 04.66.68.42.36, beatrice.lognos@umontpellier.fr
- Recruiting
Msp La Mosson
Montpellier
Ibrahim SADIKK, 0662626083, brahim588@hotmail.fr
- Recruiting
MSP Montpellier-Cévennes
Montpellier
Karolina Griffiths, 04.66.68.42.36, karoli-na.griffiths@umontpellier.fr
- Recruiting
MMG de Narbonne
Narbonne
Mélissa MORENO, 04.66.68.42.36, Mellym2212@hotmail.com
- Recruiting
Msp Narbo-Ouest
Narbonne
Jean-Baptiste TOSTAIN, 0468938819, drtostain@gmail.com
- Recruiting
CHU de Nîmes
Nîmes
Anissa Megzari, 04.66.68.42.36, drc@chu-nimes.fr
- Recruiting
MMG de Nîmes
Nîmes
Alexis Vandeventer, 04.66.68.42.36, alexis.vandeventer@umontpellier.fr
- Recruiting
MSP Charles GIDE
Nîmes
Alexis VANDEVENTER, 04.48.06.52.60, alexis.vandeventer@umontpellier.fr
- Recruiting
CABINET médical de l'Étang de l'Or
Pérols
Daniel TONDA, 07.85.82.67.72, daniel.tonda.bueso@gmail.com
- Recruiting
CABINET MEDICAL Perpignan
Perpignan
Maria FERREYRA MAILHAT, 0674921550, ferreyra.mailhat@gmail.com
- Recruiting
Mspu Pins Justaret
Pins-Justaret
Florent PORTET, 0630156467, florent.portet@dumg-toulouse.fr
- Recruiting
MSP de Pont Saint Esprit
Pont-Saint-Esprit
David Juge, 04.66.68.42.36, jugedavid@gmail.com
- Recruiting
MSPU Pauline Lautaud
Prades-le-Lez
Elodie Million, 04.66.68.42.36, elodie.million@umontpellier.fr
- Recruiting
MSP Le Prisme
Remoulins
Philippe Serayet, 04.66.68.42.36, philippe.serayet07@gmail.com
- Recruiting
Msp Du Thaurac
Saint-Bauzille-de-Putois
Murielle GLONDU-LASSIS, 06.9937.77.01, glondu-lassis@umontpellier.fr
- Recruiting
CABINET MEDICAL Saint-Hippolyte-du-Fort
Saint-Hippolyte-du-Fort
Charlotte FAURIE, 0466732503, charlotte.faurie@pole-sante-cigalois.fr
- Recruiting
Msp Saint Jean-Du Gard
Saint-Jean-du-Gard
Marion PAKEY, 0671715067, marion.pakey@gmail.com
- Recruiting
MSP Saint-Laurent d'Aigouze
Saint-Laurent-d'Aigouze
Laetitia Vailhe, 04.66.68.42.36, laetitia-vailhe@hotmail.fr
- Recruiting
MSP Sud Minervois
Saint-Marcel-sur-Aude
Mélissa MORENO, 04.66.68.42.36, Mellym2212@hotmail.com
- Recruiting
CDS Filieris Saint Martin de Valgalgues
Saint-Martin-de-Valgalgues
Adrien ROMARY, 0617441293, adrien.romary@gmail.com
- Recruiting
Maison de santé de St Quentin la Poterie
Saint-Quentin-la-Poterie
Alexandre COURT, 0466222548, courtalexandre@gmail.com
- Recruiting
MSP Pezenas Tourbes
Tourbes
Laure FERRIERES, 0678412281, laureferrieres@gmail.com
- Recruiting
Mspu La Source
Vergèze
Melanie Badin, 04.66.68.42.36, Melanie.badin@umontpellier.fr
About this study
Official 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
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
- Being tested
- Capillary CRP
- Keywords
- C-reactive protein
- Medical subject headings
- Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capillary CRPOther
CRP measured semi-quantitatively using ACTIM-CRP device
| Study group | Role | What they receive |
|---|---|---|
| Capillary CRP | Experimental | Not described Receives: Other: Capillary CRP |
| Control | No intervention | Prior to Capillary CRP condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Referral rates to any facility equipped for emergency laboratory testing between conditions
Referral: Yes/No as reported by the physician
Measured: Day 1
Referral rates to any facility equipped for emergency laboratory testing between conditions
Referral: Yes/No as reported by the parents
Measured: Day 7
Secondary outcomes (16)
Referral rates to medical biology laboratories between conditions
Referral: Yes/No as reported by the physician
Measured: Day 1
Referral rates to medical biology laboratories between conditions
Referral: Yes/No as reported by the parents
Measured: Day 7
Referral rates to emergency departments between conditions
Referral: Yes/No as reported by the physician
Measured: Day 1
Referral rates to emergency departments between conditions
Referral: Yes/No as reported by the parents
Measured: Day 7
Number complementary tests between conditions
Total number of tests as reported by the physician
Measured: Day 1
Number complementary tests between conditions
Total number of tests as reported by the parents
Measured: Day 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
Measured: Day 1
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
Measured: Day 7
GP satisfaction on care organization
0-10 visual analog scale
Measured: Day 7
The total duration of GP time between conditions
Minutes: measured as consultation time + examination time and time to inform the family
Measured: Day 7
Parent satisfaction with the care pathway
0-10 numeric scale
Measured: Day 7
Rate of antibiotic prescription between conditions
Antibiotic prescription: Yes/No as reported by the physician
Measured: Day 1
Rate of antibiotic prescription between conditions
Antibiotic prescription: Yes/No as reported by the parents
Measured: Day 7
Duration of fever episode between groups
Days counted upon reaching 24 hours without fever
Measured: Day 7
Cost-consequences between groups
euros
Measured: Day 7
Budget impact analysis
euros
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start15 Sep 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FeverStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Cluster randomized step wedge
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chloé SIKIRDJI, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06910631
- Sponsor's protocol ID
- RESPIR/2023/CS-01
- Acronym
- CRP-CAP
- Status last verified
- Jun 2026
- First submitted
- 21 Mar 2025
- Last updated
- 23 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06910631
- Acronym / sponsor ID
- CRP-CAP / RESPIR/2023/CS-01
- Conditions
- Fever
- Keywords
- C-reactive protein
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 4 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Cluster randomized step wedge
| Arm | Type | Receives |
|---|---|---|
| Capillary CRP | Experimental | Other: Capillary CRP |
| Control | No intervention | –Prior to Capillary CRP condition |
Who may qualify
- Ages
- 3 months to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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:
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Capillary CRPCRP measured semi-quantitatively using ACTIM-CRP device | Other | Capillary CRP |
Primary outcome
Referral rates to any facility equipped for emergency laboratory testing between conditions
Time frame: Day 1
Referral: Yes/No as reported by the physician
Referral rates to any facility equipped for emergency laboratory testing between conditions
Time frame: Day 7
Referral: Yes/No as reported by the parents
16 secondary outcomes
Referral rates to medical biology laboratories between conditions
Time frame: Day 1
Referral rates to medical biology laboratories between conditions
Time frame: Day 7
Referral rates to emergency departments between conditions
Time frame: Day 1
Referral rates to emergency departments between conditions
Time frame: Day 7
Number complementary tests between conditions
Time frame: Day 1
Number complementary tests between conditions
Time frame: Day 7
Type of complementary tests between conditions
Time frame: Day 1
Type of complementary tests between conditions
Time frame: Day 7
GP satisfaction on care organization
Time frame: Day 7
The total duration of GP time between conditions
Time frame: Day 7
Parent satisfaction with the care pathway
Time frame: Day 7
Rate of antibiotic prescription between conditions
Time frame: Day 1
Rate of antibiotic prescription between conditions
Time frame: Day 7
Duration of fever episode between groups
Time frame: Day 7
Cost-consequences between groups
Time frame: Day 7
Budget impact analysis
Time frame: Day 7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Derived from this study: PubMed 41638749Griffiths 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.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chloé SIKIRDJI principal investigator
Centre Hospitalier Universitaire de Nīmes
37 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Capillary CRP in people with Fever, run by Centre Hospitalier Universitaire de Nīmes at 37 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chloé SIKIRDJI (06.15.56.80.28, chloe.sikirdji@umontpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Referral rates to any facility equipped for emergency laboratory testing between conditions (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06910631, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.