SepsisNCT06267742
Clinical Trial to Evaluate MDW for Early Detection of Sepsis
An observational study of Sepsis, run by Beckman Coulter, Inc. at 3 sites in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Sepsis
- What is being tested?
- Complete Blood Count (CBC) with Differential
- How many people
- 2,200 participants
- Where
- 3 sitesChina
- Study dates
- 23 Jun 2022to 30 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients of any race and ethnicity can be enrolled to this study. Patients with a prior chronic immunosuppressive disease and subjects with hematological malignancy can also be enrolled. This study requires at least 250 sepsis subjects and 1,100 non-sepsis subjects.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
China3 sites
Peking Union Medical College Hospital
Beijing
West China Hospital, Sichuan University
Chengdu
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou
About this study
Official title: Clinical Trial to Evaluate Early Sepsis Indicator Monocyte Distribution Width (MDW) for Early Detection of Sepsis or Developing Sepsis
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.
Read the 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
- Being tested
- Complete Blood Count (CBC) with Differential
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complete Blood Count (CBC) with DifferentialDiagnostic test
CBC with Differential including Monocyte Distribution Width (MDW)
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitivity, specificity
sensitivity (percentage of patients with sepsis correctly identified), specificity (percentage of non-sepsis patients correctly identified) according to Sepsis-2
Measured: 2022.3-2024.3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start23 Jun 2022
- Primary completion31 May 2024
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beckman Coulter, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Peking Union Medical College Hospital, West China Hospital, Second Affiliated Hospital, Zhejiang University, School of Medicine
- Responsible party
- Sponsor
- Investigators
- DONG LI, MS, Study director, BECKMAN COULTER
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06267742
- Sponsor's protocol ID
- CHN097
- Status last verified
- Mar 2025
- First submitted
- 12 Feb 2024
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Evaluate Early Sepsis Indicator Monocyte Distribution Width (MDW) for Early Detection of Sepsis or Developing Sepsis
- ClinicalTrials.gov ID
- NCT06267742
- Acronym / sponsor ID
- CHN097
- Conditions
- Sepsis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,200 participants (estimated)
- Lead sponsor
- Beckman Coulter, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Peking Union Medical College Hospital, West China Hospital, Second Affiliated Hospital, Zhejiang University, School of Medicine
- Study start
- 23 Jun 2022 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of any race and ethnicity can be enrolled to this study. Patients with a prior chronic immunosuppressive disease and subjects with hematological malignancy can also be enrolled. This study requires at least 250 sepsis subjects and 1,100 non-sepsis subjects.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Complete Blood Count (CBC) with DifferentialCBC with Differential including Monocyte Distribution Width (MDW) | Diagnostic test | – |
Primary outcome
sensitivity, specificity
Time frame: 2022.3-2024.3
sensitivity (percentage of patients with sepsis correctly identified), specificity (percentage of non-sepsis patients correctly identified) according to Sepsis-2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
DONG LI, MS study director
BECKMAN COULTER
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Beckman Coulter, Inc. at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sensitivity, specificity (time frame: 2022.3-2024.3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.