Clinical Trial: Bacterial Meningitis in Adults: Analysis of the Determinants of Mortality and Neurosensory Sequelae
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational
Official Title: Bacterial Meningitis in Adults: Analysis of the Determinants of Mortality and Neurosensory Sequelae
Brief Summary:
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.
Detailed Summary:
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
Sponsor: Assistance Publique - Hôpitaux de Paris
Current Primary Outcome: In-hospital mortality [ Time Frame: 30 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Assistance Publique - Hôpitaux de Paris
Dates:
Date Received: November 15, 2012
Date Started: March 2013
Date Completion: December 2017
Last Updated: June 16, 2016
Last Verified: June 2016
