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NCT06618989: CYTOFEB
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.
trial testing Blood sampling and follow-up call in Children Under 3 Months of Age With Fever in 180 participants. Currently enrolling.
24 August 2026
Quick facts
| Lead sponsor | Assistance Publique - Hôpitaux de Paris |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 180 |
| Start date | 24 February 2025 |
| Primary completion | 24 August 2026 |
| Estimated completion | 7 September 2026 |
| Sites | 2 locations across France |
Drugs / interventions tested
- Blood sampling and follow-up call
Conditions studied
- Children Under 3 Months of Age With Fever — all drugs for Children Under 3 Months of Age With Fever →
Sponsor
Assistance Publique - Hôpitaux de Paris — full company profile →
Who can join
Adults 7 Days to 90 Days, any sex, with Children Under 3 Months of Age With Fever. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06618989
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06618989 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris
- Last refreshed: 28 February 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06618989.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing