National Bacterial Meningitis Study

Children, Only Clinical Trial

Official title:

National Observatory of Bacterial Meningitis in Children and Newborns

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04664569
• Other study ID #: Obs meningitis
• Status: Recruiting
• Start date: January 1, 2001
• Est. completion date: January 1, 2030

Study information

• Verified date: December 2022
• Source: Association Clinique Thérapeutique Infantile du val de Marne
• Contact: Corinne Levy, MD
• Phone: 0033148850404
• Email: corinne.levy[@]activ-france.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8230
• Est. completion date: January 1, 2030
• Est. primary completion date: January 1, 2030
• Gender: All
• Age group: 0 Years to 18 Years

Eligibility

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:

-

Related Conditions & MeSH terms

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

Intervention

Other:
• observational study
observational study

Locations

Country	Name	City	State
France	ACTIV	Créteil

Sponsors (2)

Lead Sponsor	Collaborator
Association Clinique Thérapeutique Infantile du val de Marne	Pfizer

Country where clinical trial is conducted

France, 

Outcome

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

External Links

•   Clinical and Laboratory Features of Group B Streptococcus Meningitis in Infants and Newborns: Study of 848 Cases in France, 2001-2014
•   Comparative impact of pneumococcal conjugate vaccines on pneumococcal meningitis according to underlying conditions
•   Incidence of paediatric pneumococcal meningitis and emergence of new serotypes: a time-series analysis of a 16-year French national survey
•   Neonatal Meningococcal Meningitis In France From 2001 To 2013
•   Outcomes of bacterial meningitis in children
•   Recurrent Pneumococcal Meningitis in Children: A Multicenter Case-control Study
•   Risk Factors in Children Older Than 5 Years With Pneumococcal Meningitis: Data From a National Network