Meningitis, Bacterial Clinical Trial
Official title:
Bacterial Meningitis in Adults: Analysis of the Determinants of Mortality and Neurosensory Sequelae
Major changes in the epidemiological characteristics of bacterial meningitis have been
observed as a result of changes in behaviour, human interventions (use of antibiotics,
prophylactic vaccinations), as well as poorly elucidated mechanisms responsible for epidemic
outbreaks.
The objective of this study is to identify the determinants of in-hospital mortality of
bacterial meningitis in adults.
Hypothesis : the standardized data collection concerning cases of bacterial meningitis in
adults with telephone follow-up would allow analysis of the determinants of mortality and
neurosensory sequelae, description of the psychosocial impact and proposal of new treatment
strategies.
Introduction: Bacterial meningitis is a rare (about 1,200 cases per year in France, 50%
occurring in adults) and serious disease (20% mortality during the acute phase; neurosensory
sequelae in 30% of survivors). Major changes in the epidemiological characteristics of
bacterial meningitis have been observed as a result of changes in behaviour, human
interventions (use of antibiotics, prophylactic vaccinations), as well as poorly elucidated
mechanisms responsible for epidemic outbreaks. No standardized clinical, microbiological and
prognostic data collection concerning bacterial meningitis in adults is available in France.
Hypothesis: Standardized data collection concerning cases of bacterial meningitis in adults
with telephone follow-up would allow analysis of the determinants of mortality and
neurosensory sequelae, description of the psychosocial impact and proposal of new treatment
strategies.
Primary objective: To identify the determinants of in-hospital mortality of bacterial
meningitis in adults.
Secondary objectives: To describe the epidemiological characteristics of community-acquired
bacterial meningitis in adults, changes in these characteristics and their relations with the
vaccine status of the affected adult and his/her family; to characterize clinical and
microbiological failures and their determinants (pharmacological, microbiological,
immunological, etc.); to analyse the determinants of neurosensory sequelae and failure to
return to work after 1 month, 6 months and 12 months.
Primary endpoint: In-hospital mortality (D30). Secondary endpoints: History including
vaccination of the case and the family, clinical, microbiological (species, susceptibility,
virulence factors, cerebrospinal fluid CSF) culture on D0 and H48), imaging characteristics;
treatments, CSF antibiotic concentrations, neurological sequelae (modified Rankin, Glasgow
Outcome Scale, IQCODE) at M1, M6 an M12, quality of life test SF12, WHO QoL, CESD) at M1, M6,
M12, hearing loss (audiometric tests, hereditary hearing impairment (HHI), telephone speech
test in noise) at M1, M6, M12.
Methodology, study design: National observational cohort study with comprehensive recruitment
in participating centres.
Legal classification of the project: Epidemiological study. Number of subjects required: The
inclusion of 150 cases of meningitis per year would allow the collection of about 450 cases
over a period of 3 years. For a mortality rate of 20%, we would be able to estimate this
percentage with a confidence interval of ± 3.7% (95% confidence interval: 16.3-23.7). With 90
deaths, a power of 80% and a level of significance of 5% (two-tailed), this sample size would
demonstrate relative risks of 1.8 for a prevalence of the risk factor of 25% and 2.6 for a
prevalence of the risk factor of 10%.
Inclusion criteria: Adult with community-acquired bacterial meningitis defined by the
presence of at least one of the following criteria: 1/ Positive CSF culture and/or positive
soluble antigen in CSF with or without cell reaction; 2/ Positive PCR in CSF; 3/ Purpura
fulminant (with or without positive CSF culture); Positive polymerase chain reaction (PCR) in
blood and/or positive blood culture AND CSF cell reaction.
Non inclusion criteria: Age less than 18 years old or refusal to participate. Inclusion
period: 3 years. Duration of participation for one patient: 12 months. Number of
participating centers: Constitution in participating centers of a dual investigator team
comprising a clinician (infectious diseases physician, intensive care physician, or
neurologist) and a microbiologist (participating in the national network of "OBSERVATOIRES
REGIONAUX DU PNEUMOCOQUE" [Regional Pneumococcal Observatories]). Declaration by the
microbiologist to the data management centre. On-site validation of cases by the dual
investigator team and then by a national multidisciplinary validation unit.
Mean number of inclusions per month and per centre: 0.5
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