NCT02198950

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2009

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
2.6 years until next milestone

First Posted

Study publicly available on registry

July 24, 2014

Completed
Last Updated

September 18, 2020

Status Verified

September 1, 2020

Enrollment Period

1.9 years

First QC Date

September 23, 2010

Last Update Submit

September 16, 2020

Conditions

Critically Ill Patients

Keywords

sepsisdiagnosisbiomarker

Outcome Measures

Primary Outcomes (1)

  • 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 (FcγRI) 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

Study Arms (1)

ICU patients

all patients admitted into the ICU

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patient admitted into the ICU

You may qualify if:

  • all consecutive patients admitted into the ICU

You may not qualify if:

  • absence of social protection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bocage Hospital

Dijon, France

Location

Central hospital

Nancy, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasmas

MeSH Terms

Conditions

SepsisDisease

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sebastien Gibot, MD, PhD

    Central Hospital, Nancy, France

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

September 23, 2010

First Posted

July 24, 2014

Study Start

November 1, 2009

Primary Completion

October 1, 2011

Study Completion

December 1, 2011

Last Updated

September 18, 2020

Record last verified: 2020-09

Locations

FR(2)