Toulouse Hospital
Toulouse, France
Location status: Recruiting
NCT Number: NCT06482463
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Toulouse, France
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
an additional CSF sample of 1 ml is taken from the external ventriculostomy
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.
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.
Time frame: Day 0
sensitivity parameter calculated for the combined assay of 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.
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.
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.
Time frame: Day 0
Sensitivity Parameter calculated for the D-lactate assay in CSF according to 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.
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.
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.
Time frame: Day 0
Densitivity Parameter calculated for the determination of D-lactate in CSF 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.
Contact information is provided by the study sponsor or research team.
Guillaume MARTIN-BLONDEL, Md
CONTACT
0561779699 ext. +33
Lucie LELIEVRE, Md
CONTACT
0561777198 ext. +33
University Hospital, Toulouse
Other
Diagnostic Significance of D-lactate in Cerebrospinal Fluid Level in Patients With Suspected Ventriculostomy-related Meningitis : a Pilot Study
Acronym: TOTEM
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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