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.
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 -80°C. 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 patient's medical records.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
185
an additional CSF sample of 1 ml is taken from the external ventriculostomy
Toulouse Hospital
Toulouse, France
RECRUITINGComparison 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.
Time frame: 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.
Time frame: Day 0
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 0