Clinical Trial to Evaluate MDW for Early Detection of Sepsis

Clinical Trial to Evaluate Early Sepsis Indicator Monocyte Distribution Width (MDW) for Early Detection of Sepsis or Developing Sepsis

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06267742

Enrollment

2200

Registered

2024-02-20

Start date

2022-06-23

Completion date

2026-09-30

Last updated

2025-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis

Brief summary

This study is intended to clinically verify Monocyte Distribution Width (MDW) parameter of DxH 900 Hematology Analyzer for use in early detection and risk assessment of sepsis, severe sepsis, and septic shock in critically ill patients in Emergency Department (ED). This study is also aimed to provide study supporting data for the product to be marketed in China.

Detailed description

To verify the clinical performance of MDW parameter in detection of sepsis through a multicenter, prospective study of adults undergoing complete blood count with differential (CBC with differential) in the ED. To clarify the cutoff 20.0 established in the pivotal trial. The cutoff was established for the objective of achieving the highest sensitivity at the optimal specificity level. Patients whose MDW value is higher than the cutoff will be identified as sepsis patients and those whose MDW value is equal to or lower than the cutoff are non-sepsis patients.

Interventions

DIAGNOSTIC_TESTComplete Blood Count (CBC) with Differential

CBC with Differential including Monocyte Distribution Width (MDW)

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 89 Years

Healthy volunteers

Inclusion criteria

* Adult subjects (18-89 years) presenting to ED. * CBC with Differential performed upon presentation as part of standard of care. * Subject scheduled for at least 12 hours follow-up during ED (or inpatient, if admitted to the hospital) visit * Signed the informed consent form

Exclusion criteria

* Subjects previously enrolled in this study (i.e., re-enrollment to this study is not allowed). * The subject is discharged from the hospital within 12 hours after ED visit

Design outcomes

Primary

Measure	Time frame	Description
sensitivity, specificity	2022.3-2024.3	sensitivity (percentage of patients with sepsis correctly identified), specificity (percentage of non-sepsis patients correctly identified) according to Sepsis-2

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026