Clinical trial NCT06482463: Diagnostic of D-lactate in Cerebrospinal Fluid Level in Patients With Suspected Ventriculostomy-related Meningitis
Official title: Diagnostic Significance of D-lactate in Cerebrospinal Fluid Level in Patients With Suspected Ventriculostomy-related Meningitis : a Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Nosocomial Infection
Keywords: External ventriculostomy
Nosocomial meningitis
Bacterial meningitis
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2024-07-01
Enrollment: 185
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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 -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.

Eligibility criteria: Inclusion Criteria:

* 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.
* Patient affiliated to a social security scheme.

Exclusion Criteria:

* 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.
* Acute mesenteric ischaemia.
* End-stage renal failure (GFR \< 15 ml/min/m2).
* Peritoneal dialysis.
* Patient participating in another research protocol with an exclusion period still in progress.
* Pregnant or breastfeeding woman.
* Patient under guardianship or trusteeship, persons placed under the protection of justice

Primary outcomes:
measure: Comparison of Sensitivity of CSF D-Lactate for Ventriculostomy-Related Nosocomial Meningitis
timeFrame: Day 0
measure: Comparison of Specificity of CSF D-Lactate for Ventriculostomy-Related Nosocomial Meningitis
timeFrame: Day 0
Secondary outcomes:
measure: sensitivity Parameter of Combined D-Lactate and Pro-Inflammatory Cytokines in CSF
timeFrame: Day 0
measure: specificity Parameter of Combined D-Lactate and Pro-Inflammatory Cytokines in CSF
timeFrame: Day 0
measure: Sensitivity Parameter of Combined D-Lactate and and cyto-biochemical parameters in CSF.
timeFrame: Day 0
measure: specificity Parameter of D-lactate and cyto-biochemical parameters in CSF.
timeFrame: Day 0
measure: Sensitivity Parameter of D-lactate in CSF depending on the nature of the bacterial species identified.
timeFrame: Day 0
measure: specificity Parameter of D-lactate in CSF depending on the nature of the bacterial species identified.
timeFrame: Day 0
measure: Sensitivity Parameter of D-lactate in CSF according to the presence or absence of antibiotic therapy before collection.
timeFrame: Day 0
measure: specificity Parameter of D-lactate in CSF according to the presence or absence of antibiotic therapy before collection.
timeFrame: Day 0
measure: Sensitivity Parameter for the determination of CSF D-lactate in culture-negative bacterial meningitis.
timeFrame: Day 0
measure: specificity Parameter for the determination of CSF D-lactate in culture-negative bacterial meningitis.
timeFrame: Day 0
Other outcomes:
Locations:
Study officials:
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