About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ⩾ 18 years.
Patient with an external ventriculostomy implanted at the Toulouse University Hospital.
Patient suspected of nosocomial meningitis due to a febrile syndrome (in the absence of any other identified infectious site), headache, nausea, lethargy, change in neurological status, meningeal syndrome, epileptic event and cutaneous or subcutaneous inflammation at the ventriculostomy site of insertion.
Patient having expressed oral consent, after free and informed information.
Disqualifiers
Diagnosis of community meningitis.
Proven or suspected meningitis and/or ventriculitis during the previous month.
Diagnosis of nosocomial meningitis made in another medical centre prior to admission.
Short bowel syndrome.
Trial design
Parallel
Treatments tested in this trial
CSF sample
Biological/Vaccinean additional CSF sample of 1 ml is taken from the external ventriculostomy
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
Secondary outcomes
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.
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.
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.
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.
Sponsors and contacts
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