National Bacterial Meningitis Study in Children and Newborns

National Observatory of Bacterial Meningitis in Children and Newborns

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04664569

Enrollment

10000

Registered

2020-12-11

Start date

2001-01-01

Completion date

2030-01-01

Last updated

2026-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antibiotic Treatment, Case Fatality Rate, Children, Only, H. Influenzae Vaccine, Meningitis, Meningococcal Vaccines, Neonatal Infection, Pneumococcal Conjugate Vaccine

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Days to 18 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
mortality	before the hospital discharge	Number of death according to age and bacteria

Secondary

Measure	Time frame	Description
treatment failures	48 hours after the antibiotic treatment and new lumbar puncture	Number of antibiotic treatment failures according to bacteria after the control of lumbar puncture
impact of vaccines	before the hospital discharge	Number of vaccination failures according to age, number of doses and bacteria

Countries

France

Contacts

CONTACTCorinne Levy, MD

corinne.levy@activ-france.fr0033148850404

CONTACTStephane Bechet

stephane.bechet@activ-france.fr1 48 85 96 68

STUDY_DIRECTORCorinne Levy, MD

Association Clinique Thérapeutique Infantile du val de Marne

PRINCIPAL_INVESTIGATORRobert Cohen