SepsisMOCORSEPNCT04292431
Leukocyte MOrphology and CORticosteroids Response in SEPtic Patients (MOCORSEP)
An observational study of Sepsis and Septic Shock, run by Beckman Coulter, Inc. at 1 site in France.
Trial summary
Non-interventional, prospective, monocentric study on the exploration of leukocyte morphological parameters according to the infectious condition and response to corticosteroid therapy of septic patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Septic Shock, Sepsis Syndrome
- How many people
- 175 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2019to 30 Dec 2020
- How long will I take part?
- 7 Days
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Non infected (n=50) Infection (n=50) Sepsis + SOFA > 2 (n=25) Sepsis (SOFA > 2) + vasopressors and lactate ≤ 2 mmol/L (n=25) Septic shock (SOFA > 2 + vasopressor + lactate > 2 mmol/L) (n=25)
Who may be able to join
- an infection (known or suspected)
- sepsis
- sepsis + vasopressor
- septic shock
- responders to corticosteroid therapy
- non-responders to corticosteroid therapy
Who cannot join
- Pregnant women
- Patients with onco-hematological diseases with the presence of blasts.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploration of Variations in Leukocyte Morphological Parameters (MDW and CPD) Using the Beckman Coulter DxH900, Based on the Infectious Condition, Inflammatory State and Response to Corticosteroid Therapy in Septic Patients
Non-interventional, prospective, monocentric study on the exploration of leukocyte morphological parameters according to the infectious condition and response to corticosteroid therapy of septic patients.
Read the detailed description
Sepsis is a major public health issue, caused by an organ disorder related to an immune response not controlled by the infection.
Several randomized trials have shown that the combination of glucocorticoids and mineralocorticoids improves the survival rate of patients in septic shock. The optimal use of this therapeutic approach requires identifying the pro-inflammatory phase patients likely to respond to corticosteroid therapy.
Hyperactivation of immune cells is accompanied by morphological changes likely to be characterized by modern hematology instruments, particularly the DxH900 (Beckman Coulter). The DxH900 is able to use specific techniques to determine a significant number of morphological characteristics (CPD or Cell Population Data) for circulating leukocytes. Recently, one of these leukocyte morphological parameters, MDW (Monocyte Distribution Width), has been clinically approved for identifying septic patients or those at risk of developing sepsis. This MDW parameter currently has the CE IVD mark and is approved by the American FDA.
The aim of the study is to explore the hypothesis that leukocyte morphological parameters, including MDW, may constitute functional biomarkers of pro-inflammatory response and help to identify septic patients likely to optimally respond to a combination treatment of glucocorticoids and mineralocorticoids, and thus improve their chances of survival.
The proposed study is a non-interventional, prospective, monocentric cohort study to explore the variation of leukocyte morphological parameters measured on the DxH900 hematology analyzer according to the different infectious conditions of patients ranging from a known or suspected infection to septic shock versus non-infected control patients, and possibly based on the response. This observational cohort study will consist of patients with a known or suspected infection, sepsis or in septic shock on their date of admission into one of the medical or surgical departments and monitored up to day 7 of the hospital stay or on the date of discharge from the hospital, whichever occurs first.
- Conditions
- Sepsis, Septic Shock, Sepsis Syndrome, Infection
- Keywords
- Leukocyte morphology, Corticosteroid, MDW, Cell population data, DxH900
- Medical subject headings
- Sepsis, Shock, Septic, Systemic Inflammatory Response Syndrome, Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Leukocytes morphological parameters differs between patient's groups
The leukocytes morphological parameters determined by DxH900 (CPD and MDW) will be compared between the patient's groups in the cohort:
- patients with infection
- patients with sepsis
- patients with septic shock
- patients with septic shock responding to corticosteroid treatment
- patients with septic shock not responding to corticosteroid treatment
Measured: 7 days
Secondary outcomes (2)
Leukocytes morphological parameters preditcs inflammatory status
Identify whether the CPD parameters differ between patients with a pro-inflammatory state for those presenting signs of immunosuppression
Measured: 7 days
Leukocytes morphological parameters preditcs responce to corticosteroids treatments
Explore the relevance of CPD parameters for predicting and monitoring the response to corticosteroid therapy in patients with septic shock.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start1 Nov 2019
- Primary completion30 Sep 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 175 participants (actual)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Beckman Coulter, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hôpital Raymond Poincaré, Saint-Louis Hospital, Paris, France
- Responsible party
- Sponsor
- Investigators
- Djillali Annane, MD, Principal investigator, Hospital Raymond PoincaréPierre Moine, MD, Study chair, Hospital Raymond PoincaréMartin Rottman, MD, Study chair, Hospital Raymond PoincaréSylvie Chevret, MD, Study chair, Hospital Saint Louis Lariboisière Fernand-Widal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04292431
- Sponsor's protocol ID
- MOCORSEP_BEC_2019
- Acronym
- MOCORSEP
- Status last verified
- Jan 2021
- First submitted
- 28 Feb 2020
- Last updated
- 29 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Annane D, Renault A, Brun-Buisson C, Megarbane B, Quenot JP, Siami S, Cariou A, Forceville X, Schwebel C, Martin C, Timsit JF, Misset B, Ali Benali M, Colin G, Souweine B, Asehnoune K, Mercier E, Chimot L, Charpentier C, Francois B, Boulain T, Petitpas F, Constantin JM, Dhonneur G, Baudin F, Combes A, Bohe J, Loriferne JF, Amathieu R, Cook F, Slama M, Leroy O, Capellier G, Dargent A, Hissem T, Maxime V, Bellissant E; CRICS-TRIGGERSEP Network. Hydrocortisone plus Fludrocortisone for Adults with Septic Shock. N Engl J Med. 2018 Mar 1;378(9):809-818. doi: 10.1056/NEJMoa1705716.
PubMed 29490185Annane D, Sebille V, Charpentier C, Bollaert PE, Francois B, Korach JM, Capellier G, Cohen Y, Azoulay E, Troche G, Chaumet-Riffaud P, Bellissant E. Effect of treatment with low doses of hydrocortisone and fludrocortisone on mortality in patients with septic shock. JAMA. 2002 Aug 21;288(7):862-71. doi: 10.1001/jama.288.7.862.
PubMed 12186604Crouser ED, Parrillo JE, Seymour C, Angus DC, Bicking K, Tejidor L, Magari R, Careaga D, Williams J, Closser DR, Samoszuk M, Herren L, Robart E, Chaves F. Improved Early Detection of Sepsis in the ED With a Novel Monocyte Distribution Width Biomarker. Chest. 2017 Sep;152(3):518-526. doi: 10.1016/j.chest.2017.05.039. Epub 2017 Jun 15.
PubMed 28625579Crouser ED, Parrillo JE, Seymour CW, Angus DC, Bicking K, Esguerra VG, Peck-Palmer OM, Magari RT, Julian MW, Kleven JM, Raj PJ, Procopio G, Careaga D, Tejidor L. Monocyte Distribution Width: A Novel Indicator of Sepsis-2 and Sepsis-3 in High-Risk Emergency Department Patients. Crit Care Med. 2019 Aug;47(8):1018-1025. doi: 10.1097/CCM.0000000000003799.
PubMed 31107278
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of Variations in Leukocyte Morphological Parameters (MDW and CPD) Using the Beckman Coulter DxH900, Based on the Infectious Condition, Inflammatory State and Response to Corticosteroid Therapy in Septic Patients
- ClinicalTrials.gov ID
- NCT04292431
- Acronym / sponsor ID
- MOCORSEP / MOCORSEP_BEC_2019
- Conditions
- Sepsis, Septic Shock, Sepsis Syndrome, Infection
- Keywords
- Leukocyte morphology, Corticosteroid, MDW, Cell population data, DxH900
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Beckman Coulter, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Hôpital Raymond Poincaré, Saint-Louis Hospital, Paris, France
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 3 Mar 2020 (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.
Non-interventional, prospective, monocentric study on the exploration of leukocyte morphological parameters according to the infectious condition and response to corticosteroid therapy of septic patients.
Detailed description
Sepsis is a major public health issue, caused by an organ disorder related to an immune response not controlled by the infection.
Several randomized trials have shown that the combination of glucocorticoids and mineralocorticoids improves the survival rate of patients in septic shock. The optimal use of this therapeutic approach requires identifying the pro-inflammatory phase patients likely to respond to corticosteroid therapy.
Hyperactivation of immune cells is accompanied by morphological changes likely to be characterized by modern hematology instruments, particularly the DxH900 (Beckman Coulter). The DxH900 is able to use specific techniques to determine a significant number of morphological characteristics (CPD or Cell Population Data) for circulating leukocytes. Recently, one of these leukocyte morphological parameters, MDW (Monocyte Distribution Width), has been clinically approved for identifying septic patients or those at risk of developing sepsis. This MDW parameter currently has the CE IVD mark and is approved by the American FDA.
The aim of the study is to explore the hypothesis that leukocyte morphological parameters, including MDW, may constitute functional biomarkers of pro-inflammatory response and help to identify septic patients likely to optimally respond to a combination treatment of glucocorticoids and mineralocorticoids, and thus improve their chances of survival.
The proposed study is a non-interventional, prospective, monocentric cohort study to explore the variation of leukocyte morphological parameters measured on the DxH900 hematology analyzer according to the different infectious conditions of patients ranging from a known or suspected infection to septic shock versus non-infected control patients, and possibly based on the response. This observational cohort study will consist of patients with a known or suspected infection, sepsis or in septic shock on their date of admission into one of the medical or surgical departments and monitored up to day 7 of the hospital stay or on the date of discharge from the hospital, whichever occurs first.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 7 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Non infected (n=50) Infection (n=50) Sepsis + SOFA > 2 (n=25) Sepsis (SOFA > 2) + vasopressors and lactate ≤ 2 mmol/L (n=25) Septic shock (SOFA > 2 + vasopressor + lactate > 2 mmol/L) (n=25)
Key inclusion criteria (6 listed)
- an infection (known or suspected)
- sepsis
- sepsis + vasopressor
- septic shock
Key exclusion criteria (2 listed)
- Pregnant women
- Patients with onco-hematological diseases with the presence of blasts.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Leukocytes morphological parameters differs between patient's groups
Time frame: 7 days
The leukocytes morphological parameters determined by DxH900 (CPD and MDW) will be compared between the patient's groups in the cohort: * patients with infection * patients with sepsis * patients with septic shock * patients with septic shock responding to corticosteroid treatment * patients with septic shock not responding to corticosteroid treatment
2 secondary outcomes
Leukocytes morphological parameters preditcs inflammatory status
Time frame: 7 days
Leukocytes morphological parameters preditcs responce to corticosteroids treatments
Time frame: 7 days
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 29 Jan 2021.
- Background: PubMed 29490185Annane D, Renault A, Brun-Buisson C, Megarbane B, Quenot JP, Siami S, Cariou A, Forceville X, Schwebel C, Martin C, Timsit JF, Misset B, Ali Benali M, Colin G, Souweine B, Asehnoune K, Mercier E, Chimot L, Charpentier C, Francois B, Boulain T, Petitpas F, Constantin JM, Dhonneur G, Baudin F, Combes A, Bohe J, Loriferne JF, Amathieu R, Cook F, Slama M, Leroy O, Capellier G, Dargent A, Hissem T, Maxime V, Bellissant E; CRICS-TRIGGERSEP Network. Hydrocortisone plus Fludrocortisone for Adults with Septic Shock. N Engl J Med. 2018 Mar 1;378(9):809-818. doi: 10.1056/NEJMoa1705716.
- Background: PubMed 12186604Annane D, Sebille V, Charpentier C, Bollaert PE, Francois B, Korach JM, Capellier G, Cohen Y, Azoulay E, Troche G, Chaumet-Riffaud P, Bellissant E. Effect of treatment with low doses of hydrocortisone and fludrocortisone on mortality in patients with septic shock. JAMA. 2002 Aug 21;288(7):862-71. doi: 10.1001/jama.288.7.862.
- Background: PubMed 28625579Crouser ED, Parrillo JE, Seymour C, Angus DC, Bicking K, Tejidor L, Magari R, Careaga D, Williams J, Closser DR, Samoszuk M, Herren L, Robart E, Chaves F. Improved Early Detection of Sepsis in the ED With a Novel Monocyte Distribution Width Biomarker. Chest. 2017 Sep;152(3):518-526. doi: 10.1016/j.chest.2017.05.039. Epub 2017 Jun 15.
- Background: PubMed 31107278Crouser ED, Parrillo JE, Seymour CW, Angus DC, Bicking K, Esguerra VG, Peck-Palmer OM, Magari RT, Julian MW, Kleven JM, Raj PJ, Procopio G, Careaga D, Tejidor L. Monocyte Distribution Width: A Novel Indicator of Sepsis-2 and Sepsis-3 in High-Risk Emergency Department Patients. Crit Care Med. 2019 Aug;47(8):1018-1025. doi: 10.1097/CCM.0000000000003799.
- 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.
Djillali Annane, MD principal investigator
Hospital Raymond Poincaré
Pierre Moine, MD study chair
Hospital Raymond Poincaré
Martin Rottman, MD study chair
Hospital Raymond Poincaré
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Septic Shock, run by Beckman Coulter, Inc. at 1 site in France.
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 6 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: finished, as of the sponsor's last update on 29 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Leukocytes morphological parameters differs between patient's groups (time frame: 7 days). 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 NCT04292431, which also lists 4 linked publications.
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 29 Jan 2021.