Molecular Culture, Cerebrospinal fluid, Neonatal bacterial meningitis, Pediatric bacterial meningitis Molecular Culture, Brain fluid, Neonatal bacterial brain infection, Pediatric bacterial brain infection
Conditions
Interventions
This study is observational in nature and does not involve any intervention that alters the child’s clinical management. The study consists solely of analyzing cerebrospinal fluid (CSF) using a molecu
Sponsors
Máxima MC
Eligibility
Age
No minimum to 17 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a participant must meet all of the following criteria:Undergoing lumbar puncture (LP) for suspected meningitis as part of routine clinical care, or having undergone LP for suspected meningitis within the past 72 hours, with CSF stored or available for analysisAge 0–18 yearsInformed consent obtained from parent(s) or legal guardian, or from the participant if appropriate.
Exclusion criteria
Exclusion criteria: There are no specific exclusion criteria for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| This study aims to determine whether the molecular culture technique can more accurately detect the presence of bacteria in CSF than the conventional CSF culture currently used in clinical practice, in children with suspected bacterial meningitis. The study will also assess whether molecular culture can provide results more rapidly. Additionally, the study will evaluate whether molecular culture can detect bacteria in situations where the conventional CSF culture often remains negative, for example when antibiotics have already been administered before the lumbar puncture is performed. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcomes include evaluating how Molecular Culture (MC) compares with conventional CSF diagnostics in a head-to-head manner, and assessing its performance against the clinical diagnosis of bacterial meningitis, which is based on clinical signs, CSF parameters and additional diagnostic investigations.The study will also record how often treating physicians actively request the MC result in infants with clear clinical signs of meningitis but a negative conventional CSF culture. Exploratory subgroup analyses will examine the influence of factors such as prior antibiotic exposure, age category and CSF sample volume on diagnostic performance. | — |
Countries
Netherlands
Contacts
Public ContactH.J. Niemarkt
Máxima MC
Outcome results
None listed