National Bacterial Meningitis Study in Children and Newborns

NCT04664569 | Recruiting DMC

• 1 other identifier: Obs meningitis
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• mortality

  Number of death according to age and bacteria

  before the hospital discharge

Secondary Outcomes (2)

• treatment failures

  48 hours after the antibiotic treatment and new lumbar puncture

• impact of vaccines

  before the hospital discharge

Interventions

observational study

Eligibility Criteria

• Age: 1 Day - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

children 0 day to 18 years with bacterial meningitis or purpura fulminans

You may qualify if:

• 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

Sponsors & Collaborators

• Pfizer: collaborator
• Association Clinique Thérapeutique Infantile du val de Marne: lead

Study Sites (1)

ACTIV

Créteil, France

RECRUITING

Related Publications (3)

• Maunier L, Levy C, Baron A, Weill FX, Bechet S, Pardos de la Gandara M, Caseris M, Abdoul C, Dommergues MA, Cohen R, Bonacorsi S. Retrospective Description of 27 Cases of Nontyphoidal Salmonella Meningitis in Pediatrics Over 22 Years in France Pleads for a Revision of Age Limit for the Treatment of Salmonella Gastroenteritis in Children. Pediatr Infect Dis J. 2026 Jan 1;45(1):e10-e12. doi: 10.1097/INF.0000000000004966. Epub 2025 Sep 3.

  PMID: 40924727 DERIVED

• Fafi I, Cohen R, Levy C, Varon E, Amor-Chelihi L, Benhaim P, Houlier M, Koehl B, De Montalembert M, Allali S, Gauthier A, Odievre MH, Gajdos V, Escoda S, Kamdem A, Costa G, Guillaumat C, Thuret I, Ouldali N, Gaschignard J, Carbonnelle E, De Pontual L, Pham LL. High Mortality Due to Pneumococcal Meningitis in Children With Sickle Cell Disease: A French Multicenter Observational Study From 2001 to 2021. Pediatr Infect Dis J. 2025 Jun 1;44(6):496-502. doi: 10.1097/INF.0000000000004755. Epub 2025 Mar 7.

  PMID: 40063777 DERIVED

• Rybak A, Ouldali N, Varon E, Taha MK, Bonacorsi S, Bechet S, Angoulvant F, Cohen R, Levy C; French Pediatric Meningitis Network. Vaccine-preventable Pediatric Acute Bacterial Meningitis in France: A Time Series Analysis of a 19-Year Prospective National Surveillance Network. Pediatr Infect Dis J. 2024 Jan 1;43(1):74-83. doi: 10.1097/INF.0000000000004134. Epub 2023 Nov 13.

  PMID: 38108805 DERIVED

Related Links

• Recurrent Pneumococcal Meningitis in Children: A Multicenter Case-control Study
• Incidence of paediatric pneumococcal meningitis and emergence of new serotypes: a time-series analysis of a 16-year French national survey
• Clinical and Laboratory Features of Group B Streptococcus Meningitis in Infants and Newborns: Study of 848 Cases in France, 2001-2014
• Risk Factors in Children Older Than 5 Years With Pneumococcal Meningitis: Data From a National Network
• Neonatal Meningococcal Meningitis In France From 2001 To 2013
• Comparative impact of pneumococcal conjugate vaccines on pneumococcal meningitis according to underlying conditions
• Outcomes of bacterial meningitis in children
• Vaccine-preventable Pediatric Acute Bacterial Meningitis in France: A Time Series Analysis of a 19-Year Prospective National Surveillance Network
• Increase of Haemophilus influenzae type b meningitis, beyond initial findings
• Adjunctive dexamethasone and 30-day all-cause death after hospital admission in paediatric pneumococcal meningitis: a propensity score analysis
• High Mortality Due to Pneumococcal Meningitis in Children With Sickle Cell Disease: A French Multicenter Observational Study From 2001 to 2021

MeSH Terms

Conditions

Meningitis

Condition Hierarchy (Ancestors)

Neuroinflammatory Diseases; Nervous System Diseases

Study Officials

• Corinne Levy, MD

  Association Clinique Thérapeutique Infantile du val de Marne

  STUDY DIRECTOR

• Robert Cohen

  Association Clinique Thérapeutique Infantile du val de Marne

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Corinne Levy, MD

CONTACT

0033148850404; corinne.levy@activ-france.fr

Stephane Bechet

CONTACT

1 48 85 96 68; stephane.bechet@activ-france.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2020
• First Posted: December 11, 2020
• Study Start: January 1, 2001
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030
• Last Updated: April 28, 2026

Record last verified: 2026-04

Locations

FR (1)