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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Toulouse

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • CSF sample

    Biological/Vaccine

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

Treatment groups

185 Participants
are divided into 2 treatment groups
Group A: Ventriculostomy-related nosocomial meningitisExperimental treatment 1 intervention
Group B: Absence of nosocomial meningitisOther 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Day 0
2

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

Secondary outcomes

1

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
2

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
3

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
4

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.

Time frame
Day 0

Other outcomes

Sponsors and contacts

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