Ignite Creation Date:
2024-05-06 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06155266
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2023-11-13
Brief Title:
Combination of Leukocyte Cell Surface Biomarkers Measured by Cytometry to Differentiate Bacterial From Viral Infections in Emergency Department a Multicentric Cohort for the Validation of Diagnostic Performances
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Combination of Leukocyte Cell Surface Biomarkers Measured by Cytometry to Differentiate Bacterial From Viral Infections in Emergency Department a Multicentric Cohort for the Validation of Diagnostic Performances
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CYTOBACT
Brief Summary:
The characterization of the bacterial or viral etiology of an infectious event is required for both isolation decisions and rationale use of antibiotics In emergency room ER the direct identification of the causal pathogen is rarely available in real-time Alternative is the identification of the host-response to either a bacterial or viral infection One of this host-response is the expression of peripheral leukocytes cell surface markers measured by flow cytometry Investigators and others have reported the high diagnostic performances of combination of cell surface biomarkers to differentiate bacterial from viral infection The CYTOBACT study aims to confirm on a 500 patients multicentric cohort 200 having already been collected during another study SEPTIMET the best combinations for this diagnostic issue
The study will be conducted in 3 emergency departments of APHP hospitals network in Paris France Patients with a suspicion of infection will be proposed to participate No intervention will be introduced during the routine care in the ER which will be let at the discretion of the treating emergency physician During the routine blood sampling in the ER an additional 30 ml volume of whole blood will be collected centrifugated aliquoted and stored at -80C for further measurement of the expression of a panel of cell surface markers The participants will be followed up during their hospitalization if any and no longer than 28 days Clinical data at admission usual blood tests and all microbiological investigations performed during the hospital stay will be recorded into an electronic case record form eCRF Based on all those recorded data excepted the results of flow cytometry for cell surface biomarkers 2 independent adjudicators will qualify the infectious episode into bacterialviral or no infection and if any into infection sepsis or septic shock according to Sepsis 30 definitions
Using different machine learning statistical tools all the combination of the cell surface biomarkers will be tested to select those with the highest performance to differentiate bacterial from viral infection
The study will be conducted in 3 emergency departments of APHP hospitals network in Paris France Patients with a suspicion of infection will be proposed to participate No intervention will be introduced during the routine care in the ER which will be let at the discretion of the treating emergency physician During the routine blood sampling in the ER an additional 30 ml volume of whole blood will be collected centrifugated aliquoted and stored at -80C for further measurement of the expression of a panel of cell surface markers The participants will be followed up during their hospitalization if any and no longer than 28 days Clinical data at admission usual blood tests and all microbiological investigations performed during the hospital stay will be recorded into an electronic case record form eCRF Based on all those recorded data excepted the results of flow cytometry for cell surface biomarkers 2 independent adjudicators will qualify the infectious episode into bacterialviral or no infection and if any into infection sepsis or septic shock according to Sepsis 30 definitions
Using different machine learning statistical tools all the combination of the cell surface biomarkers will be tested to select those with the highest performance to differentiate bacterial from viral infection
Detailed Description:
Patients attending the ED of one of the participant centers for a suspicion of infection will be informed and asked to participate After obtaining a non-opposition to participate during the routine blood sampling performed in the ER an additional volume of 30 ml of whole blood will be collected aliquoted and stored at -80C comprising notably 12 ml of whole blood to which 1 ml of Cytodelics Stabiliser will be added and incubated à room temperature for 10 mn before being aliquoted and stored at -80C The remaining whole blood will be collected on EDTA and Paxgen tubes centrifugated aliquoted and stored at -80C for blood collection
Clinical data at admission past medical history vital parameters infectious source if any treatments delivered in the ER will be recorded into an eCRF The participants will be followed up until leaving the hospital and no longer than day-28 All the microbiology tests performed during the hospital stay will be also recorded into eCRF The diagnostic performance of the combinations of cell surface markers will be evaluated against a diagnostic reference on the bacterial of viral qualification of each infectious event This diagnostic reference will be established by an independant expert comitee after reviewing all the clinical and biological data recorded excepted the results of flow cytometry in order to adjudicate between bacterial viral or no infection and among infected patients to classify into infection sepsis or septic shock sepsis 30
After completing the recruitement of participants a panel of cell surface markers will be measured by batch on a spectral cytometer comprising notably the biomarkers of interest already published HLA-DR CD169 and CX3CR1 on monocytes and MerTk CD64 and CD24 on neutrophils
The performances of the combinations of cell surface markers already identified in the littérature will be tested prioritarily However in order to refine the best combinations of biomarkers to discriminate bacterial from viral infection machine learning algorithms like gradient boosting tree and support vector machine tools will be applied on the entire results of cell surface markers measured The diagnostic performance will be evaluated calculating the sensitivity specificity area under the ROC curve of the biomarkers combinations selected
Clinical data at admission past medical history vital parameters infectious source if any treatments delivered in the ER will be recorded into an eCRF The participants will be followed up until leaving the hospital and no longer than day-28 All the microbiology tests performed during the hospital stay will be also recorded into eCRF The diagnostic performance of the combinations of cell surface markers will be evaluated against a diagnostic reference on the bacterial of viral qualification of each infectious event This diagnostic reference will be established by an independant expert comitee after reviewing all the clinical and biological data recorded excepted the results of flow cytometry in order to adjudicate between bacterial viral or no infection and among infected patients to classify into infection sepsis or septic shock sepsis 30
After completing the recruitement of participants a panel of cell surface markers will be measured by batch on a spectral cytometer comprising notably the biomarkers of interest already published HLA-DR CD169 and CX3CR1 on monocytes and MerTk CD64 and CD24 on neutrophils
The performances of the combinations of cell surface markers already identified in the littérature will be tested prioritarily However in order to refine the best combinations of biomarkers to discriminate bacterial from viral infection machine learning algorithms like gradient boosting tree and support vector machine tools will be applied on the entire results of cell surface markers measured The diagnostic performance will be evaluated calculating the sensitivity specificity area under the ROC curve of the biomarkers combinations selected
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None