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

NCT06482463 | Recruiting

• 1 other identifier: RC31/23/0614
• Study Type: interventional
• Target: 185
• Locations: 1 country
• Sites: 1

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.

Conditions

Nosocomial Infection

Keywords

External ventriculostomy; Nosocomial meningitis; Bacterial meningitis

Outcome Measures

Primary Outcomes (2)

• 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.

  Day 0

• 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.

  Day 0

Secondary Outcomes (10)

• sensitivity Parameter of Combined D-Lactate and Pro-Inflammatory Cytokines in CSF

  Day 0

• specificity Parameter of Combined D-Lactate and Pro-Inflammatory Cytokines in CSF

  Day 0

• Sensitivity Parameter of Combined D-Lactate and and cyto-biochemical parameters in CSF.

  Day 0

• specificity Parameter of D-lactate and cyto-biochemical parameters in CSF.

  Day 0

• Sensitivity Parameter of D-lactate in CSF depending on the nature of the bacterial species identified.

  Day 0

Study Arms (2)

Ventriculostomy-related nosocomial meningitis

EXPERIMENTAL

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

Biological: CSF sample

Absence of nosocomial meningitis

OTHER

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

Biological: CSF sample

Interventions

CSF sample BIOLOGICAL

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

Absence of nosocomial meningitis; Ventriculostomy-related nosocomial meningitis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Pregnant or breastfeeding woman.
• Patient under guardianship or trusteeship, persons placed under the protection of justice

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

Toulouse Hospital

Toulouse, France

RECRUITING

MeSH Terms

Conditions

Cross Infection; Meningitis, Bacterial

Condition Hierarchy (Ancestors)

Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Central Nervous System Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Central Nervous System Infections; Central Nervous System Diseases; Nervous System Diseases; Meningitis; Neuroinflammatory Diseases

Central Study Contacts

Lucie LELIEVRE, Md

CONTACT

0561777198; lelievre.l@chu-toulouse.fr

Guillaume MARTIN-BLONDEL, Md

CONTACT

0561779699; martin-blondel.g@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: July 1, 2024
• Study Start: February 12, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: December 31, 2025

Record last verified: 2025-12

Locations

FR (1)