National Observatory of Bacterial Meningitis in Children and Newborns
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 10,000
- Locations
- 1
- Primary Endpoint
- mortality
Study Overview
Brief Summary
Bacterial meningitis is a major cause of morbidity and mortality in childhood. Antibiotic treatment recommendations are based on epidemiological and susceptibility data. The epidemiology of bacterialméningitis has changed in recent years, mainly owing to widespread use of different conjugate vaccines. The aim of this prospective national survey is to describe epidemiology of bacteria implicated in bacterial meningitis in children.
Detailed Description
For children under 18, hospitalized for bacterial meningitis, the following data will be analyzed: risk factors, vaccination status, signs of symptoms, treatment during hospitalization, analysis (cerebrospinal fluid culture, cerebrospinal fluid antigen test, blood culture...), symptoms or clinic signs of illness.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 1 Day to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •clinical signs of meningitis, associated with positive cerebrospinal fluid (CSF) culture and/or positive CSF antigen testing (Escherichia coli K1, N. meningitidis serogroups B, A, C, Y and W-135, group B streptococci, Hib, or S. pneumoniae), and/or positive CSF polymerase chain reaction (PCR), and/or positive blood culture with CSF pleocytosis (> 10 cells/µL).
- •purpura fulminans
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
mortality
Time Frame: before the hospital discharge
Number of death according to age and bacteria
Secondary Outcomes
- treatment failures(48 hours after the antibiotic treatment and new lumbar puncture)
- impact of vaccines(before the hospital discharge)