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Clinical Trials in France / NCT06482463
Recruiting Not applicable

Diagnostic of D-lactate in Cerebrospinal Fluid Level in Patients With Suspected Ventriculostomy-related Meningitis

NCT06482463 · tracked via the Priya Life Science France tracker
Sponsor
University Hospital, Toulouse
Phase
Not applicable
Started
2025-02-12
Last updated
2025-12-31

Condition(s) studied

Nosocomial Infection

Investigational drug(s) / intervention(s)

CSF sample

CSF sample: an additional CSF sample of 1 ml is taken from the external ventriculostomy

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)

  • Comparison of Sensitivity of CSF D-Lactate for Ventriculostomy-Related Nosocomial Meningitis — Day 0
    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 — Day 0
    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.

Trial sites (1)

FacilityCityRegionStatus
Toulouse Hospital Toulouse France Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06482463 on ClinicalTrials.gov ↗ ← All trials in France