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

December 23, 2025 updated by: University Hospital, Toulouse

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
185

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Biological: CSF sample
an additional CSF sample of 1 ml is taken from the external ventriculostomy
Other: 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.
Biological: CSF sample
an additional CSF sample of 1 ml is taken from the external ventriculostomy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Comparison of Sensitivity of CSF D-Lactate for Ventriculostomy-Related Nosocomial Meningitis
Time Frame: Day 0
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
Time Frame: Day 0
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
sensitivity Parameter of Combined D-Lactate and Pro-Inflammatory Cytokines in CSF
Time Frame: Day 0
sensitivity parameter calculated for the combined assay of D-lactate and pro-inflammatory cytokines in CSF.
Day 0
specificity Parameter of Combined D-Lactate and Pro-Inflammatory Cytokines in CSF
Time Frame: Day 0
specificity parameter calculated for the combined assay of D-lactate and pro-inflammatory cytokines in CSF.
Day 0
Sensitivity Parameter of Combined D-Lactate and and cyto-biochemical parameters in CSF.
Time Frame: Day 0
sensitivity parameter calculated for the combined assay of D-lactate and routinely assayed cyto-biochemical parameters (L-lactate, proteins, glucose, cellularity) in CSF.
Day 0
specificity Parameter of D-lactate and cyto-biochemical parameters in CSF.
Time Frame: Day 0
specificity parameter calculated for the combined assay of D-lactate and routinely assayed cyto-biochemical parameters (L-lactate, proteins, glucose, cellularity) in CSF.
Day 0
Sensitivity Parameter of D-lactate in CSF depending on the nature of the bacterial species identified.
Time Frame: Day 0
Sensitivity Parameter calculated for the D-lactate assay in CSF according to the nature of the bacterial species identified.
Day 0
specificity Parameter of D-lactate in CSF depending on the nature of the bacterial species identified.
Time Frame: Day 0
specificity Parameter calculated for the D-lactate assay in CSF according to the nature of the bacterial species identified.
Day 0
Sensitivity Parameter of D-lactate in CSF according to the presence or absence of antibiotic therapy before collection.
Time Frame: Day 0
Sensitivity Parameter calculated for the determination of D-lactate in CSF according to the presence or absence of antibiotic therapy prior to sampling.
Day 0
specificity Parameter of D-lactate in CSF according to the presence or absence of antibiotic therapy before collection.
Time Frame: Day 0
specificity Parameter calculated for the determination of D-lactate in CSF according to the presence or absence of antibiotic therapy prior to sampling.
Day 0
Sensitivity Parameter for the determination of CSF D-lactate in culture-negative bacterial meningitis.
Time Frame: Day 0
Densitivity Parameter calculated for the determination of D-lactate in CSF in culture-negative bacterial meningitis.
Day 0
specificity Parameter for the determination of CSF D-lactate in culture-negative bacterial meningitis.
Time Frame: Day 0
specificity Parameter calculated for the determination of D-lactate in CSF in culture-negative bacterial meningitis.
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Toulouse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 12, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 25, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 1, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 31, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 23, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RC31/23/0614

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings