Severe InfectionNCT03588325
Evaluation of MDW for Early Detection of Sepsis, Clinical Validity
An observational study of Severe Infection and Sepsis, run by Beckman Coulter, Inc. at 2 sites in 2 countries.
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… Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Severe Infection, Sepsis, Severe Sepsis
- What is being tested?
- CBC-DIFF with MDW, PCT, CRP
- How many people
- 947 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 8 Aug 2018to 30 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Study population: All adults with suspicion of infection who present to the Emergency Department and for whom a CBC-DIFF is ordered upon presentation
Who may be able to join
- CBC-DIFF upon presentation
- Adults (18-89) of all races \& ethnicities
- Signed Informed Consent
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Evaluation of MDW for Early Detection of Sepsis In the Emergency Department
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).
Read the detailed 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
- Conditions
- Severe Infection, Sepsis, Severe Sepsis
- Being tested
- CBC-DIFF with MDW, PCT, CRP
- Keywords
- MDW, Sepsis
- Medical subject headings
- Infections, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBC-DIFF with MDW, PCT, CRPDiagnostic test
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of sepsis based on Sepsis-2 criteria
Determination of diagnostic accuracy based on Receiver Operating Characteristic Curves
Measured: Within 4 hours of presentation
Secondary outcomes (1)
Identification of sepsis based on Sepsis-3 criteria
Determination of diagnostic accuracy based on Receiver Operating Characteristic Curves
Measured: Within 4 hours of presentation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2018
- Study start8 Aug 2018
- Primary completion2 Aug 2019
- Study completion30 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Severe InfectionStudies 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
- 947 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beckman Coulter, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pierre Hausfater, MD, Principal investigator, Groupe Hospitalier Pitie-Salpetriere
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03588325
- Sponsor's protocol ID
- C26841
- Status last verified
- Nov 2019
- First submitted
- 6 Jul 2018
- Last updated
- 22 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hausfater P, Robert Boter N, Morales Indiano C, Cancella de Abreu M, Marin AM, Pernet J, Quesada D, Castro I, Careaga D, Arock M, Tejidor L, Velly L. Monocyte distribution width (MDW) performance as an early sepsis indicator in the emergency department: comparison with CRP and procalcitonin in a multicenter international European prospective study. Crit Care. 2021 Jun 30;25(1):227. doi: 10.1186/s13054-021-03622-5.
PubMed 34193208
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of MDW for Early Detection of Sepsis In the Emergency Department
- ClinicalTrials.gov ID
- NCT03588325
- Acronym / sponsor ID
- C26841
- Conditions
- Severe Infection, Sepsis, Severe Sepsis
- Keywords
- MDW, Sepsis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 947 participants (actual)
- Lead sponsor
- Beckman Coulter, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Aug 2018 (actual)
- Primary completion
- 2 Aug 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 17 Jul 2018 (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.
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).
Detailed 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All adults with suspicion of infection who present to the Emergency Department and for whom a CBC-DIFF is ordered upon presentation
Key inclusion criteria (3 listed)
- CBC-DIFF upon presentation
- Adults (18-89) of all races \& ethnicities
- Signed Informed Consent
Key exclusion criteria (7 listed)
- Previously enrolled
- Incomplete Informed Consent
- Subject discharged <4 hours from presentation
- PCT or CRP not performed per protocol
- Pregnancy
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 |
|---|---|---|
| CBC-DIFF with MDW, PCT, CRPTests 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 | Diagnostic test | – |
Primary outcome
Identification of sepsis based on Sepsis-2 criteria
Time frame: Within 4 hours of presentation
Determination of diagnostic accuracy based on Receiver Operating Characteristic Curves
1 secondary outcome
Identification of sepsis based on Sepsis-3 criteria
Time frame: Within 4 hours of presentation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2019.
- Derived from this study: PubMed 34193208Hausfater P, Robert Boter N, Morales Indiano C, Cancella de Abreu M, Marin AM, Pernet J, Quesada D, Castro I, Careaga D, Arock M, Tejidor L, Velly L. Monocyte distribution width (MDW) performance as an early sepsis indicator in the emergency department: comparison with CRP and procalcitonin in a multicenter international European prospective study. Crit Care. 2021 Jun 30;25(1):227. doi: 10.1186/s13054-021-03622-5.
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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.
Pierre Hausfater, MD principal investigator
Groupe Hospitalier Pitie-Salpetriere
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Infection and Sepsis, run by Beckman Coulter, Inc. at 2 sites in 2 countries.
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 3 inclusion and 7 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: finished, as of the sponsor's last update on 22 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France, Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Identification of sepsis based on Sepsis-2 criteria (time frame: Within 4 hours of presentation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03588325, which also lists 1 linked publication.
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 22 Nov 2019.