Molecular Early Sepsis Identification Study

UnknownOBSERVATIONAL
Enrollment

120

Participants

Timeline

Start Date

April 12, 2023

Primary Completion Date

April 17, 2023

Study Completion Date

April 30, 2024

Conditions
SepsisMolecular Diagnosis
Interventions
DIAGNOSTIC_TEST

Septicyte Rapid ®

SeptiCyte RAPID is based on the measurement of two gene expression biomarkers in peripheral blood (PLAC8 and PLA2G7) using quantitative reverse transcription-polymerase chain reaction (RT-qPCR). Based on the results obtained in 1 hour from whole blood (100 mcl), the device issues a report with a sepsis probability scale according to 4 bands (1 low probability, 2-3 intermediate probability and 4 high probability).

DIAGNOSTIC_TEST

FilmArray® blood culture identification (BCID2®)

After 6 to 8 hours of blood culture incubation, BCID2 will be performed on each of the 4 bottles. The BCID2 assay is an approved molecular test for the direct identification of pathogens causing bloodstream infections from blood cultures. The BCID2 Panel analyzes 43 targets associated with bloodstream infections, including Gram-negative bacteria, Gram-positive bacteria, yeasts and 10 antimicrobial resistance genes, all with a single test and with results available in approximately one hour from the blood culture. In addition, the BCID2® Panel menu includes seven additional resistance genes, including carbapenemases, colistin resistance genes and a MREJ assay that enables more specific MRSA identification.

Trial Locations (1)

43007

RECRUITING

Alejandro Rodriguez, Tarragona

Sponsors

Collaborators (2)

All Listed Sponsors
collaborator

BioMérieux

INDUSTRY

collaborator

Biocartis NV

INDUSTRY

lead

Alejandro Rodriguez Oviedo , MD

OTHER