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

NCT ID: NCT06482463

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

185 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-12

Study Completion Date

2027-02-28

Brief Summary

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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

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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.

Conditions

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Nosocomial Infection

Keywords

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External ventriculostomy Nosocomial meningitis Bacterial meningitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Ventriculostomy-related nosocomial meningitis

Finally, two neurosurgical reanimators will retrospectively diagnose nosocomial meningitis, or the absence of meningitis, according to the information from the patient's medical records.

Group Type EXPERIMENTAL

CSF sample

Intervention Type BIOLOGICAL

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

Absence of nosocomial meningitis

Finally, two neurosurgical reanimators will retrospectively diagnose nosocomial meningitis, or the absence of meningitis, according to the information from the patient's medical records.

Group Type OTHER

CSF sample

Intervention Type BIOLOGICAL

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

Interventions

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CSF sample

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Toulouse Hospital

Toulouse, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Lucie LELIEVRE, Md

Role: CONTACT

Phone: 0561777198

Email: [email protected]

Guillaume MARTIN-BLONDEL, Md

Role: CONTACT

Phone: 0561779699

Email: [email protected]

Facility Contacts

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Guillaume MARTIN-BLONDEL

Role: primary

Other Identifiers

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RC31/23/0614

Identifier Type: -

Identifier Source: org_study_id