Evaluation of bioMarkErs to Reduce Antibiotics Use in hospitalizeD nEonates

NACompletedINTERVENTIONAL
Enrollment

233

Participants

Timeline

Start Date

November 22, 2017

Primary Completion Date

November 20, 2020

Study Completion Date

November 20, 2020

Conditions
Late-Onset Neonatal Sepsis
Interventions
BIOLOGICAL

Diagnostic performances of biomarkers combination

"A blood sample of 400µL will be drawn at inclusion, when neonatal sepsis is suspected, at the same time of a venipuncture prescribed for standard care.~The dosage of 11 biomarkers will be performed in a central laboratory. The adjudication committee composed with 3 neonatalogists will classify patients in 3 groups (infected, not infected or unclassified patients), based on their clinical and biological data obtained, through the standard of care practice, during the 48 hours following inclusion. The adjudication committee will be blinded to the biomarkers results.~The adjudication committee composed with 3 neonatalogists will classify patients in 3 groups (infected, not infected or unclassified patientsconfirmed infection, refuted infection), based on their clinical and biological data obtained, through the standard of care practice, during the 48 hours following inclusion. The adjudication committee will be blinded to the biomarkers results."

Trial Locations (2)

69500

Hospices Civils de Lyon, Bron

Unknown

CHU de Nantes, Nantes

All Listed Sponsors
lead

Hospices Civils de Lyon

OTHER

NCT03299751 - Evaluation of bioMarkErs to Reduce Antibiotics Use in hospitalizeD nEonates | Biotech Hunter | Biotech Hunter