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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02198950
Other study ID # 2009-A00870-57
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 2009
Est. completion date December 2011

Study information

Verified date September 2020
Source Central Hospital, Nancy, France
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to determine wether the combined measurement of the soluble form of TREM-1, PCT and the determination of neutrophils CD64 expression could diagnose sepsis in critically ill patients.


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Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Bocage Hospital Dijon
France Central hospital Nancy

Sponsors (1)

Lead Sponsor Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Accuracy of sTREM-1, PCT, and CD64, taken alone or in combination in diagnosing sepsis in ICU patients as defined by the expert panel A prospective study will be conducted in 300 patients admitted to a medical Intensive Care Unit, assaying serum concentrations of soluble Triggering Receptor Expressed on Myeloid cells-1 (sTREM-1) and procalcitonin (PCT), and measuring the expression of the high affinity immunoglobulin-Fc fragment receptor I (Fc?RI) CD64 on neutrophils (PMN CD64 index) in flow cytometry. These biomarkers will be tested for their association with the diagnosis of infection. The final diagnosis of infection will be done by independent experts blinded for the results of CD64, sTREM-1, and PCT results. A "Bioscore" combining these biomarkers will be constructed and validated in an independent prospective cohort from another center. 28 days
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