Clinical Trial to Evaluate MDW for Early Detection of Sepsis

Active, not recruiting

• Conditions: Sepsis

• Registration Number: NCT06267742
• Lead Sponsor: Beckman Coulter, Inc.

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.

Study Timeline

• Study Start: 2022-06-23
• Study First Submitted: 2024-02-12
• Study First Submitted QC: 2024-02-12
• Study First Posted: 2024-02-20
• Primary Completion: 2024-05-31
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-05
• Last Update Posted: 2025-03-06
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 2200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Peking Union Medical College Hospital; 🇨🇳 Beijing, China

West China Hospital, Sichuan University; 🇨🇳 Chengdu, China

The Second Affiliated Hospital of Zhejiang University School of Medicine; 🇨🇳 Hangzhou, China