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Recruiting NCT06482463

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

No phase Interventional Nosocomial Infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CSF sample.
Who it may be relevant to
Registry conditions: Nosocomial Infection. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Diagnostic Significance of D-lactate in Cerebrospinal Fluid Level in Patients With Suspected Ventriculostomy-related Meningitis : a Pilot Study

Overview

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.

Interventions

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

Primary outcome measures

  • Comparison of Sensitivity of CSF D-Lactate for Ventriculostomy-Related Nosocomial Meningitis [Time frame: Day 0]
  • Comparison of Specificity of CSF D-Lactate for Ventriculostomy-Related Nosocomial Meningitis [Time frame: Day 0]
Secondary outcome measures (10)
  • sensitivity Parameter of Combined D-Lactate and Pro-Inflammatory Cytokines in CSF [Time frame: Day 0]
  • specificity Parameter of Combined 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. [Time frame: Day 0]
  • specificity Parameter of D-lactate and cyto-biochemical parameters in CSF. [Time frame: Day 0]
  • Sensitivity Parameter of D-lactate in CSF depending on 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. [Time frame: Day 0]
  • Sensitivity Parameter of D-lactate in CSF according to the presence or absence of antibiotic therapy before collection. [Time frame: Day 0]
  • specificity Parameter of D-lactate in CSF according to the presence or absence of antibiotic therapy before collection. [Time frame: Day 0]
  • Sensitivity Parameter for the determination of CSF D-lactate in culture-negative bacterial meningitis. [Time frame: Day 0]
  • specificity Parameter for the determination of CSF D-lactate in culture-negative bacterial meningitis. [Time frame: Day 0]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

France · 1 center
  • Toulouse Hospital — Toulouse

Identifiers

NCT: NCT06482463 · RC31/23/0614

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗