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Molecular Early Sepsis Identification Study

NCT05833412 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2023-05-03

No results posted yet for this study

Summary

Single-center, retrospective observational study to evaluate the implementation of early molecular diagnosis of sepsis using SeptiCyte and BCID2 in 120 critically ill patients with suspected sepsis without clear focus and requiring antimicrobial treatment.

The main objective is to evaluate the performance of these molecular techniques with respect to routine clinical practice and their impact on the optimization of antimicrobial treatment in this group of patients.

Conditions

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.

Sponsors & Collaborators

  • BioMérieux

    collaborator INDUSTRY

  • Biocartis NV

    collaborator INDUSTRY

  • Alejandro Rodriguez Oviedo , MD

    lead OTHER

Principal Investigators

  • ALEJANDRO RODRIGUEZ, MD,PhD,MSc · Hospital Universitari de Tarragona Joan XXIII

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-12
Primary Completion
2023-04-17
Completion
2024-04-30
FDA Device
Yes

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05833412 on ClinicalTrials.gov