Nosocomial InfectionTOTEMNCT06482463
Diagnostic of D-lactate in Cerebrospinal Fluid Level in Patients With Suspected Ventriculostomy-related Meningitis
A study testing CSF sample in people with Nosocomial Infection, run by University Hospital, Toulouse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nosocomial Infection
- What is being tested?
- CSF sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 185 participants
- Where
- 1 siteFrance
- Study dates
- 12 Feb 2025to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Toulouse Hospital
Toulouse
Guillaume MARTIN-BLONDEL, 0561778490, martin-blondel.g@chu-toulouse.fr
About this study
Official title: 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.
Read the 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.
- Conditions
- Nosocomial Infection
- Being tested
- CSF sample
- Keywords
- External ventriculostomy, Nosocomial meningitis, Bacterial meningitis
- Medical subject headings
- Cross Infection, Meningitis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSF sampleBiological
an additional CSF sample of 1 ml is taken from the external ventriculostomy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Biological: CSF sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 0
Secondary outcomes (10)
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.
Measured: Day 0
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.
Measured: Day 0
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.
Measured: Day 0
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.
Measured: Day 0
Sensitivity Parameter of D-lactate in CSF depending on the nature of the bacterial species identified.
Sensitivity Parameter calculated for the D-lactate assay in CSF according to the nature of the bacterial species identified.
Measured: Day 0
specificity Parameter of D-lactate in CSF depending on the nature of the bacterial species identified.
specificity Parameter calculated for the D-lactate assay in CSF according to the nature of the bacterial species identified.
Measured: Day 0
Sensitivity Parameter of D-lactate in CSF according to the presence or absence of antibiotic therapy before collection.
Sensitivity Parameter calculated for the determination of D-lactate in CSF according to the presence or absence of antibiotic therapy prior to sampling.
Measured: Day 0
specificity Parameter of D-lactate in CSF according to the presence or absence of antibiotic therapy before collection.
specificity Parameter calculated for the determination of D-lactate in CSF according to the presence or absence of antibiotic therapy prior to sampling.
Measured: Day 0
Sensitivity Parameter for the determination of CSF D-lactate in culture-negative bacterial meningitis.
Densitivity Parameter calculated for the determination of D-lactate in CSF in culture-negative bacterial meningitis.
Measured: Day 0
specificity Parameter for the determination of CSF D-lactate in culture-negative bacterial meningitis.
specificity Parameter calculated for the determination of D-lactate in CSF in culture-negative bacterial meningitis.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study start12 Feb 2025
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nosocomial InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 185 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06482463
- Sponsor's protocol ID
- RC31/23/0614
- Acronym
- TOTEM
- Status last verified
- Dec 2025
- First submitted
- 25 Jun 2024
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Significance of D-lactate in Cerebrospinal Fluid Level in Patients With Suspected Ventriculostomy-related Meningitis : a Pilot Study
- ClinicalTrials.gov ID
- NCT06482463
- Acronym / sponsor ID
- TOTEM / RC31/23/0614
- Conditions
- Nosocomial Infection
- Keywords
- External ventriculostomy, Nosocomial meningitis, Bacterial meningitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 185 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 12 Feb 2025 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 1 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ventriculostomy-related nosocomial meningitis | Experimental | Biological: CSF sampleFinally, two neurosurgical reanimators will retrospectively diagnose nosocomial meningitis, or the absence of meningitis, according to the information from the patient's medical records. |
| Absence of nosocomial meningitis | Other | Biological: CSF sampleFinally, two neurosurgical reanimators will retrospectively diagnose nosocomial meningitis, or the absence of meningitis, according to the information from the patient's medical records. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CSF samplean additional CSF sample of 1 ml is taken from the external ventriculostomy | Biological | Absence of nosocomial meningitis, Ventriculostomy-related nosocomial meningitis |
Primary outcome
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.
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.
10 secondary outcomes
sensitivity Parameter of Combined D-Lactate and Pro-Inflammatory Cytokines in CSF
Time frame: Day 0
specificity Parameter of Combined D-Lactate and Pro-Inflammatory Cytokines in CSF
Time frame: Day 0
Sensitivity Parameter of Combined D-Lactate and and cyto-biochemical parameters in CSF.
Time frame: Day 0
specificity Parameter of D-lactate and cyto-biochemical parameters in CSF.
Time frame: Day 0
Sensitivity Parameter of D-lactate in CSF depending on the nature of the bacterial species identified.
Time frame: Day 0
specificity Parameter of D-lactate in CSF depending on the nature of the bacterial species identified.
Time frame: Day 0
Sensitivity Parameter of D-lactate in CSF according to the presence or absence of antibiotic therapy before collection.
Time frame: Day 0
specificity Parameter of D-lactate in CSF according to the presence or absence of antibiotic therapy before collection.
Time frame: Day 0
Sensitivity Parameter for the determination of CSF D-lactate in culture-negative bacterial meningitis.
Time frame: Day 0
specificity Parameter for the determination of CSF D-lactate in culture-negative bacterial meningitis.
Time frame: Day 0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
Related trials for Nosocomial Infection
Not yet recruiting
Evaluation of an AI-Assisted Tool for CLABSI Surveillance at VA Medical Centers
Central Line-Associated Bloodstream Infection (CLABSI), Bacteremia
Active, not recruitingObservational study
Initial and Subsequent Healthcare-Associated Infections in Intensive Care Patients
Cross Infection, Intensive Care Units
Not yet recruitingObservational study
Traditional Chinese Medicine in Multidrug-Resistant Bacterial Pneumonia
Multi Drug Resistant Infections, Pneumnia
Not yet recruitingObservational study
Early Identification of Pathogens in Children With Respiratory Tract Infection by Mechanical Ventilation Using mNGS
VAP - Ventilator Associated Pneumonia
RecruitingPhase 4
EaRly impAct theraPy With Ceftazidime-avibactam Via rapID Diagnostics
Blood Stream Infections, Ventilator Associated Pneumonia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CSF sample in people with Nosocomial Infection, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lucie LELIEVRE, Md (0561777198 ext. +33, lelievre.l@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of Sensitivity of CSF D-Lactate for Ventriculostomy-Related Nosocomial Meningitis (time frame: Day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.