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

Recruiting now · Not applicable

Conditions studied: Nosocomial Infection

In brief

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.

Key facts

Study ID

NCT06482463

Run by

University Hospital, Toulouse

People needed

185

Starts

2025-02-12

Expected to finish

2027-02-01

Last updated by the study team

2025-12-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.
• 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

Where it is running

• Toulouse Hospital — Toulouse, France (enrolling)

Full record on ClinicalTrials.gov

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