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Recruiting NCT04664569

National Bacterial Meningitis Study in Children and Newborns

Observational Meningitis Children, Only Pneumococcal Conjugate Vaccine Meningococcal Vaccines

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Meningitis, Children, Only, Pneumococcal Conjugate Vaccine, Meningococcal Vaccines. Basic parameters: 1 Day — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

National Observatory of Bacterial Meningitis in Children and Newborns

Overview

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.

Primary outcome measures

  • mortality [Time frame: before the hospital discharge]
Secondary outcome measures (2)
  • treatment failures [Time frame: 48 hours after the antibiotic treatment and new lumbar puncture]
  • impact of vaccines [Time frame: before the hospital discharge]

Eligibility criteria

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

\-

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

France · 1 center
  • ACTIV — Créteil

Publications

  • 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 PMID 40924727
  • 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 2 PMID 40063777
  • 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

Identifiers

NCT: NCT04664569 · Obs meningitis

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗