Status:
RECRUITING
Validation of Biomarkers Performance to Reduce Antibiotics overUse in newBorns With Suspected Clinical Signs of InfectionS
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Neonatal Late Onset Sepsis
Eligibility:
All Genders
7-14 years
Brief Summary
Late-onset neonatal sepsis (LOS), occurring in newborn of at least 7 days of life, is frequently observed in Neonatal Intensive Care Units (NICUs) and potentially severe (mortality, neurologic and res...
Eligibility Criteria
Inclusion
- Patient hospitalized in the NICU of one of the two recruiting centers at the time of inclusion
- Patients aged ≥ 7 days
- Patients weighted ≥ 500 g the day of blood sample
- patients with suggestive signs of LOS including at least one of the following:Fever \> 38°C; tachycardia \> 160bpm; capillary refill time \> 3 seconds; grey and/or pale skin complexion; apnea/ bradycardia syndrome, bloating; vomiting; rectal bleeding; hypotonia; lethargy; seizures without other obvious cause; increased ventilatory support and/or increased FiO2; cutaneous rash; inflammation at the needle-puncture site of the central venous catheter; or any other condition for which the clinician suspected an infection
- patients with a standard of care blood sampling, including at least a blood culture;
Exclusion
- Patient treated with antibiotics for a bacteriologically confirmed infection at the time of sampling or within 48 hours prior to sampling
- Patient who underwent surgery within the previous 7 days
- Patients vaccinated within the previous 7 days
- Patient who received treatment with systemic corticosteroid therapy in the 48 hours prior to sampling
- Patient with severe combined immunodeficiency
- Opposition from parent(s)/guardian(s)
Key Trial Info
Start Date :
November 22 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
358 Patients enrolled
Trial Details
Trial ID
NCT06058819
Start Date
November 22 2023
End Date
May 1 2027
Last Update
September 3 2025
Active Locations (3)
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1
neonatal Intensive care unit, Hôpital Femme Mère Enfant, Hospices Civils de Lyon, France
Bron, France, 69500
2
Hôpital Couple-Enfant - CHU Grenoble Alpes
Grenoble, France, 38700
3
Neonatal intensive care unit, Hôpital femme-maternité
Nantes, France, 44300