National Bacterial Meningitis Study

Recruiting

• Conditions: Children, Only; H. Influenzae Vaccine; Neonatal Infection; Case Fatality Rate; Meningococcal Vaccines; Meningitis; Pneumococcal Conjugate Vaccine; Antibiotic Treatment
• Interventions: Other: observational study

• Registration Number: NCT04664569
• Lead Sponsor: Association Clinique Thérapeutique Infantile du val de Marne

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

Not available

Study Timeline

• Study Start: 2001-01-01
• Study First Submitted: 2020-12-07
• Study First Submitted QC: 2020-12-07
• Study First Posted: 2020-12-11
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-22
• Last Update Posted: 2022-12-27
• Primary Completion: 2030-01-01
• Study Completion: 2030-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 8230

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort of bacterial meningitis in children	observational study	-

Primary Outcome Measures

Name	Time	Method
mortality	before the hospital discharge	Number of death according to age and bacteria

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

ACTIV; 🇫🇷 Créteil, France