Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06618989
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-18
Brief Title:
Diagnostic Performance of a Combination of Leukocyte Cell Surface Markers in Predicting the Risk of Severe Bacterial Infection in Febrile Children Under Three Months of Age in the Emergency Department a Pilot Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Diagnostic Performance of a Combination of Leukocyte Cell Surface Markers in Predicting the Risk of Severe Bacterial Infection in Febrile Children Under Three Months of Age in the Emergency Department a Pilot Study CYTOFEB
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CYTOFEB
Brief Summary:
Fever is a frequent reason for emergency department ED visits in infants under 3 months of age Although viral infections are the most common etiologies the prevalence of severe bacterial infections SBI is high 10 While in infants with SBI establishing the diagnosis and initiating rapid intravenous antibiotic therapy is necessary every effort should be made to avoid it in those at low risk of SBI
Clinical examination and biomarkers are still sub-optimal for assessing the risk of SBI As a result the vast majority of these children receive inpatient intravenous antibiotic therapy
Flow cytometry is a technique for measuring the expression of biomarkers on the cell surface of leukocytes in response to infection A French team has identified a combination of some fifteen leukocyte cell surface markers that perform excellently in discriminating between bacterial and viral infections in a population of adults presenting to the emergency department with a suspected infection However there are no similar studies in children
The objective of the study is to assess the diagnostic performance of a combination of biomarkers on the cell surface of leukocytes in discriminating between bacterial and viral infection Infants less than 3 months of age visiting the ED for fever will have an extra blood sample in order to measure those biomarkers The performance of those biomarkers to identify SBI will be assessed
Clinical examination and biomarkers are still sub-optimal for assessing the risk of SBI As a result the vast majority of these children receive inpatient intravenous antibiotic therapy
Flow cytometry is a technique for measuring the expression of biomarkers on the cell surface of leukocytes in response to infection A French team has identified a combination of some fifteen leukocyte cell surface markers that perform excellently in discriminating between bacterial and viral infections in a population of adults presenting to the emergency department with a suspected infection However there are no similar studies in children
The objective of the study is to assess the diagnostic performance of a combination of biomarkers on the cell surface of leukocytes in discriminating between bacterial and viral infection Infants less than 3 months of age visiting the ED for fever will have an extra blood sample in order to measure those biomarkers The performance of those biomarkers to identify SBI will be assessed
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None