NCT06267742

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
• Phase: —
• Study type: Observational
• Enrollment: 2,200 (estimated)
• Sponsor: Beckman Coulter, Inc. · Industry
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sepsis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Complete Blood Count (CBC) with Differential	CBC with Differential including Monocyte Distribution Width (MDW)

Timeline

• Start date: 2022-06-23
• Primary completion: 2024-05-31
• Completion: 2026-09-30
• First posted: 2024-02-20
• Last updated: 2025-03-06

Locations

3 sites across 1 country: China

Regulatory

• FDA-regulated device study