biomArkers to differeNtiate bacTerial From vIral iNfEctions

NACompletedINTERVENTIONAL
Enrollment

983

Participants

Timeline

Start Date

June 6, 2017

Primary Completion Date

June 12, 2019

Study Completion Date

June 12, 2019

Conditions
Infection, BacterialInfection Viral
Interventions
BIOLOGICAL

Diagnostic performances of a combination of biomarkers

"3 ml of blood will be drawn at inclusion at the same time of the venipuncture prescribed for standard care. The dosage of the 7 biomarkers will be performed in a central laboratory. The adjudication committee will classify patients in 6 groups, based on their clinical data. The committee will not be aware of the biological results. The analysis of Train Set data will aim to identify the most effective combination of markers in response to the primary objective of identifying biomarkers for the diagnosis of severe bacterial infections. The best combination selected will then be applied to the Test Set data (approximately the other half of patients), in order to obtain its real and unbiased performance.~The calculation of positive and negative likelihood ratios will be performed.~The targeted performances are:~* A positive likelihood ratio (LR +) of 5.67 minimum, ideally greater than 8.5.~* A negative likelihood ratio (LR-) of 0.5 maximum, ideally less than 0.3."

Trial Locations (3)

69500

Hospices Civils de Lyon, Bron

69655

Hôpital Nord Ouest, Gleizé

92700

Hôpital Louis Mourier - APHP, Colombes

All Listed Sponsors
lead

Hospices Civils de Lyon

OTHER

NCT03163628 - biomArkers to differeNtiate bacTerial From vIral iNfEctions | Biotech Hunter | Biotech Hunter