Ignite Creation Date:
2024-07-17 @ 10:59 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06482463
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-01
First Post:
2024-06-25
Brief Title:
Diagnostic of D-lactate in Cerebrospinal Fluid Level in Patients With Suspected Ventriculostomy-related Meningitis
Sponsor:
University Hospital Toulouse
Organization:
University Hospital Toulouse
Study Overview
Official Title:
Diagnostic Significance of D-lactate in Cerebrospinal Fluid Level in Patients With Suspected Ventriculostomy-related Meningitis a Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
TOTEM
Brief Summary:
The TOTEM study is a single-center study designed to evaluate the performance of the D-lactate assay in cerebrospinal fluid CSF for the diagnosis of ventriculostomy-related nosocomial meningitis The study will be conducted in the neurosurgical intensive care unit of the Toulouse University Hospital in patients with a suspected diagnosis of ventriculostomy-related nosocomial meningitis
Detailed Description:
For each study participant an additional CSF sample will be taken from the ventriculostomy during the routine sampling performed for the diagnosis of nosocomial meningitis This sample will be stored at -80C Assays of D-lactate procalcitonin PCT and pro-inflammatory cytokines IL-1 IL-6 IL-8 TNFa will be performed serially on these CSF samples
If the CSF sample taken at inclusion does not meet the criteria for nosocomial meningitis a second sample will be taken 48 to 96 hours later to reassess the cellularity of the CSF Finally the end-of-participation visit takes place after 4 weeks Two neurosurgical reanimators will retrospectively diagnose nosocomial meningitis or the absence of meningitis according to the information from the patients medical records
If the CSF sample taken at inclusion does not meet the criteria for nosocomial meningitis a second sample will be taken 48 to 96 hours later to reassess the cellularity of the CSF Finally the end-of-participation visit takes place after 4 weeks Two neurosurgical reanimators will retrospectively diagnose nosocomial meningitis or the absence of meningitis according to the information from the patients medical records
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