Diagnostic of D-lactate in Cerebrospinal Fluid Level in Patients With Suspected Ventriculostomy-related Meningitis
NCT Number: NCT06482463
Acronym: TOTEM
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Nosocomial Infection
Interventions: BIOLOGICAL: CSF sample
Sponsor: University Hospital, Toulouse
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 185
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-09-01
Completion Date: 2026-10-01

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.

Primary Outcome Measures: Comparison of Sensitivity of CSF D-Lactate for Ventriculostomy-Related Nosocomial Meningitis, Calculation of the sensitivity obtained for the determination of CSF D-lactate in patients with suspected ventriculostomy-related nosocomial meningitis. Thes parameter will be compared with those obtained for the usual biological markers., Day 0|Comparison of Specificity of CSF D-Lactate for Ventriculostomy-Related Nosocomial Meningitis, Calculation of the specificity obtained for the determination of CSF D-lactate in patients with suspected ventriculostomy-related nosocomial meningitis. Thes parameter will be compared with those obtained for the usual biological markers., Day 0
Secondary Outcome Measures: sensitivity Parameter of Combined D-Lactate and Pro-Inflammatory Cytokines in CSF, sensitivity parameter calculated for the combined assay of D-lactate and pro-inflammatory cytokines in CSF., Day 0|specificity Parameter of Combined D-Lactate and Pro-Inflammatory Cytokines in CSF, specificity parameter calculated for the combined assay of D-lactate and pro-inflammatory cytokines in CSF., Day 0|Sensitivity Parameter of Combined D-Lactate and and cyto-biochemical parameters in CSF., sensitivity parameter calculated for the combined assay of D-lactate and routinely assayed cyto-biochemical parameters (L-lactate, proteins, glucose, cellularity) in CSF., Day 0|specificity Parameter of D-lactate and cyto-biochemical parameters in CSF., specificity parameter calculated for the combined assay of D-lactate and routinely assayed cyto-biochemical parameters (L-lactate, proteins, glucose, cellularity) in CSF., Day 0|Sensitivity Parameter of D-lactate in CSF depending on the nature of the bacterial species identified., Sensitivity Parameter calculated for the D-lactate assay in CSF according to the nature of the bacterial species identified., Day 0|specificity Parameter of D-lactate in CSF depending on the nature of the bacterial species identified., specificity Parameter calculated for the D-lactate assay in CSF according to the nature of the bacterial species identified., Day 0|Sensitivity Parameter of D-lactate in CSF according to the presence or absence of antibiotic therapy before collection., Sensitivity Parameter calculated for the determination of D-lactate in CSF according to the presence or absence of antibiotic therapy prior to sampling., Day 0|specificity Parameter of D-lactate in CSF according to the presence or absence of antibiotic therapy before collection., specificity Parameter calculated for the determination of D-lactate in CSF according to the presence or absence of antibiotic therapy prior to sampling., Day 0|Sensitivity Parameter for the determination of CSF D-lactate in culture-negative bacterial meningitis., Densitivity Parameter calculated for the determination of D-lactate in CSF in culture-negative bacterial meningitis., Day 0|specificity Parameter for the determination of CSF D-lactate in culture-negative bacterial meningitis., specificity Parameter calculated for the determination of D-lactate in CSF in culture-negative bacterial meningitis., Day 0