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NCT Number: NCT04664569

National Bacterial Meningitis Study in Children and Newborns

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.

Recruiting

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Key information

Conditions

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

Age range

1 day–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Primary outcomes

  1. mortality

    Time frame: before the hospital discharge

    Number of death according to age and bacteria

Secondary outcomes

  1. treatment failures

    Time frame: 48 hours after the antibiotic treatment and new lumbar puncture

    Number of antibiotic treatment failures according to bacteria after the control of lumbar puncture

  2. impact of vaccines

    Time frame: before the hospital discharge

    Number of vaccination failures according to age, number of doses and bacteria

Study contacts

Contact information is provided by the study sponsor or research team.

Corinne Levy, MD

CONTACT

[email protected]

0033148850404

Stephane Bechet

CONTACT

[email protected]

1 48 85 96 68 ext. +33

Sponsors and collaborators

Lead sponsor

Association Clinique Thérapeutique Infantile du val de Marne

Other

Collaborators

  • Pfizer

Registry information

Official study title

National Observatory of Bacterial Meningitis in Children and Newborns

Important dates

Study start
2001
Primary completion
2030
Study completion
2030
First posted
Dec 11, 2020
Registry last updated
Apr 28, 2026

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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