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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03588325
Other study ID # C26841
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 8, 2018
Est. completion date August 30, 2019

Study information

Verified date November 2019
Source Beckman Coulter, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to confirm the clinical validity and the performance of the Monocyte Width Distribution (MDW) parameter to detect the development of sepsis in a prospective study of Emergency Department (ED) adults who have blood draw including Complete Blood Count with differential (CBC-DIFF) ordered upon presentation in a Spanish & French hospital and to verify cut-off for Tri-potassium ethylenediaminetetraacetic acid (K3EDTA).


Description:

To confirm the clinical validity and performance of the Monocyte Width Distribution (MDW) parameter to detect the development of sepsis in a prospective study of ED adults who have blood draw including CBC with Differential ordered upon ED presentation. Septic patients are identified as those with values equal to or above the MDW threshold and non-septic patients are those with MDW values below the threshold. As the anticoagulant used at the sites is K3EDTA, the cut-off value will be assessed using sepsis cases and all corresponding non-sepsis to confirm optimal cut-off.

To explore the added value of this parameter in a patient diagnostic pathway that includes the use of procalcitonin (PCT) or C reactive protein (CRP) for the identification of septic patients All enrolled subjects will have PCT/ CRP assay performed per protocol Plasma will be aliquot and stored frozen for subsequent testing at Beckman Coulter for other sepsis biomarker tests (additional PCT& CRP tests and interleukin-6 (IL-6) on the sponsor's devices


Recruitment information / eligibility

Status Completed
Enrollment 947
Est. completion date August 30, 2019
Est. primary completion date August 2, 2019
Accepts healthy volunteers
Gender All
Age group 18 Years to 89 Years
Eligibility Inclusion Criteria:

- CBC-DIFF upon presentation

- Adults (18-89) of all races & ethnicities

- Signed Informed Consent

Exclusion Criteria:

- Previously enrolled

- Incomplete Informed Consent

- Subject discharged <4 hours from presentation

- PCT or CRP not performed per protocol

- Pregnancy

- Prisoners

- Subjects Under Custody or Guardianship

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
CBC-DIFF with MDW, PCT, CRP
Tests will be run to determine early identification of sepsis and added value of the combination of tests. Results will not be used to manage patients

Locations

Country Name City State
France La Pitié-Salpétrière Paris
Spain Hospital Universitari Germans Trias I Pujol Badalona

Sponsors (1)

Lead Sponsor Collaborator
Beckman Coulter, Inc.

Countries where clinical trial is conducted

France,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Identification of sepsis based on Sepsis-2 criteria Determination of diagnostic accuracy based on Receiver Operating Characteristic Curves Within 4 hours of presentation
Secondary Identification of sepsis based on Sepsis-3 criteria Determination of diagnostic accuracy based on Receiver Operating Characteristic Curves Within 4 hours of presentation
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