Children Under 3 Months of Age With FeverCYTOFEBNCT06618989
Diagnostic Performance of a Combination of Leukocyte Cell Surface Markers in Predicting the Risk of Severe Bacterial Infection in Febrile Children Under Three Months of Age in the Emergency Department: a Pilot Study.
An observational study of Children Under 3 Months of Age With Fever, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial summary
Fever is a frequent reason for emergency department (ED) visits in infants under 3 months of age. Although viral infections are the most common etiologies, the prevalence of severe bacterial infections (SBI) is high (10%). Read more about this study
- Who is it for?
- Ages 7 to 90 days
- Conditions the study is for
- Children Under 3 Months of Age With Fever
- What is being tested?
- Blood sampling and follow-up call
- How many people
- 180 participants
- Where
- 2 sitesFrance
- Study dates
- 24 Feb 2025to 7 Sep 2027
- Phase
- Observational
- 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 7 to 90 days
- All sexes
- No healthy volunteers
- Child
Study population: All infants aged between 7 and 90 days presenting to emergency departments with fever.
Who may be able to join
- Children aged between 7 and 90 days
- Visiting the emergency department with fever (Temperature greater than or equal to 38° measured rectally in the emergency department or reported by parents) OR whose fever is detected during the emergency department visit (Temperature greater than or equal to 38° measured rectally in the emergency department)
- Consent signed by one of the two parents/guardians
Who cannot join
- Weight less than 2,500 grams
- Chronic illness (heart failure...)
- Known immune deficiency
- Congenital anomaly significantly modifying the probability of bacterial infection (pulmonary malformation, esophageal atresia...)
- Antibiotic therapy in the previous 48 hours
- Clinically evident source of fever: skin infection, joint infection, etc.
- Parents or guardians unable to understand French
- Non-affiliation with a social security scheme (including AME)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Sorbonne University, pediatric emergency department, Trousseau hospital
Paris, France, 75012
Maxime Enault, MD, +33 1 71 73 82 97, maxime.enault@aphp.fr
Romain Guedj, MD, romain.guedj@aphp.fr
- Not yet recruiting
hospitalpediatric emergency department, Trousseau hospital
Paris, 75012
Maxime Enault, MD, +33 171738297, maxime.enault@aphp.fr
About this study
Official title: Diagnostic Performance of a Combination of Leukocyte Cell Surface Markers in Predicting the Risk of Severe Bacterial Infection in Febrile Children Under Three Months of Age in the Emergency Department: a Pilot Study. ( CYTOFEB )
Fever is a frequent reason for emergency department (ED) visits in infants under 3 months of age. Although viral infections are the most common etiologies, the prevalence of severe bacterial infections (SBI) is high (10%). While in infants with SBI, establishing the diagnosis and initiating rapid intravenous antibiotic therapy is necessary, every effort should be made to avoid it in those at low risk of SBI.
Clinical examination and biomarkers are still sub-optimal for assessing the risk of SBI. As a result, the vast majority of these children receive inpatient intravenous antibiotic therapy.
Read more
Flow cytometry is a technique for measuring the expression of biomarkers on the cell surface of leukocytes in response to infection. A French team has identified a combination of some fifteen leukocyte cell surface markers that perform excellently in discriminating between bacterial and viral infections in a population of adults presenting to the emergency department with a suspected infection. However, there are no similar studies in children.
The objective of the study is to assess the diagnostic performance of a combination of biomarkers on the cell surface of leukocytes in discriminating between bacterial and viral infection. Infants less than 3 months of age, visiting the ED for fever will have an extra blood sample in order to measure those biomarkers. The performance of those biomarkers to identify SBI will be assessed.
- Being tested
- Blood sampling and follow-up call
- Keywords
- fever, diagnostic, severe bacterial infections
- Medical subject headings
- Fever, Disease, Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampling and follow-up callOther
An additional 1.5 mL of blood will be collected at the time of the child care in the pediatric emergency department. In addition, a telephone call for patient follow-up (unless still hospitalized) will be done.
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance of a combination of leukocyte cell surface markers for identifying IBS in febrile infants under 3 months of age presenting to emergency departments.
Diagnostic performance (sensitivity and specificity) of the best performing combination of cell surface markers for identifying BSI in febrile infants under 3 months of age presenting to emergency departments.
Measured: At inclusion (D0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start24 Feb 2025
- Primary completion24 Aug 2027 (estimated)
- Study completion7 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children Under 3 Months of Age With FeverStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Pasteur Institute, Centre de recherche en épidémiologie et bio statistiques, Groupe Hospitalier Pitie-Salpetriere, Centre d'immunologie et des maladies infectieuses
- Responsible party
- Sponsor
- Investigators
- Maxime Enault, MD, Principal investigator, Sorbonne University, hospitalpediatric emergency department, Trousseau hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06618989
- Sponsor's protocol ID
- APHP231307
- Acronym
- CYTOFEB
- Status last verified
- Apr 2026
- First submitted
- 18 Sep 2024
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l\'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Performance of a Combination of Leukocyte Cell Surface Markers in Predicting the Risk of Severe Bacterial Infection in Febrile Children Under Three Months of Age in the Emergency Department: a Pilot Study. ( CYTOFEB )
- ClinicalTrials.gov ID
- NCT06618989
- Acronym / sponsor ID
- CYTOFEB / APHP231307
- Keywords
- fever, diagnostic, severe bacterial infections
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Pasteur Institute, Centre de recherche en épidémiologie et bio statistiques, Groupe Hospitalier Pitie-Salpetriere, Centre d'immunologie et des maladies infectieuses
- Study start
- 24 Feb 2025 (actual)
- Primary completion
- 24 Aug 2027 (estimated)
- Study completion
- 7 Sep 2027 (estimated)
- First posted
- 1 Oct 2024 (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 a frequent reason for emergency department (ED) visits in infants under 3 months of age. Although viral infections are the most common etiologies, the prevalence of severe bacterial infections (SBI) is high (10%). While in infants with SBI, establishing the diagnosis and initiating rapid intravenous antibiotic therapy is necessary, every effort should be made to avoid it in those at low risk of SBI.
Clinical examination and biomarkers are still sub-optimal for assessing the risk of SBI. As a result, the vast majority of these children receive inpatient intravenous antibiotic therapy.
Flow cytometry is a technique for measuring the expression of biomarkers on the cell surface of leukocytes in response to infection. A French team has identified a combination of some fifteen leukocyte cell surface markers that perform excellently in discriminating between bacterial and viral infections in a population of adults presenting to the emergency department with a suspected infection. However, there are no similar studies in children.
The objective of the study is to assess the diagnostic performance of a combination of biomarkers on the cell surface of leukocytes in discriminating between bacterial and viral infection. Infants less than 3 months of age, visiting the ED for fever will have an extra blood sample in order to measure those biomarkers. The performance of those biomarkers to identify SBI will be assessed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 7 to 90 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All infants aged between 7 and 90 days presenting to emergency departments with fever.
Key inclusion criteria (3 listed)
- Children aged between 7 and 90 days
- Visiting the emergency department with fever (Temperature greater than or equal to 38° measured rectally in the emergency department or reported by parents) OR whose fever is detected during the emergency department visit (Temperature greater than or equal to 38° measured rectally in the emergency department)
- Consent signed by one of the two parents/guardians
Key exclusion criteria (8 listed)
- Weight less than 2,500 grams
- Chronic illness (heart failure...)
- Known immune deficiency
- Congenital anomaly significantly modifying the probability of bacterial infection (pulmonary malformation, esophageal atresia...)
- Antibiotic therapy in the previous 48 hours
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 |
|---|---|---|
| Blood sampling and follow-up callAn additional 1.5 mL of blood will be collected at the time of the child care in the pediatric emergency department. In addition, a telephone call for patient follow-up (unless still hospitalized) will be done. | Other | – |
Primary outcome
Diagnostic performance of a combination of leukocyte cell surface markers for identifying IBS in febrile infants under 3 months of age presenting to emergency departments.
Time frame: At inclusion (D0)
Diagnostic performance (sensitivity and specificity) of the best performing combination of cell surface markers for identifying BSI in febrile infants under 3 months of age presenting to emergency departments.
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 22 Apr 2026.
- Individual participant dataSharing planned: Yes. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l\'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations
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.
Maxime Enault, MD principal investigator
Sorbonne University, hospitalpediatric emergency department, Trousseau hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Children Under 3 Months of Age With Fever, run by Assistance Publique - Hôpitaux de Paris at 2 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 3 inclusion and 8 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 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 Maxime Enault, MD (+33 171738297, maxime.enault@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance of a combination of leukocyte cell surface markers for identifying IBS in febrile infants under 3 months of age presenting to emergency departments. (time frame: At inclusion (D0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Apr 2026.