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Bacterial Meningitis in Adults: Analysis of the Determinants of Mortality and Neurosensory Sequelae (COMBAT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01730690
First Posted: November 21, 2012
Last Update Posted: July 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
  Purpose

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.


Condition
Meningitis, Bacterial

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Bacterial Meningitis in Adults: Analysis of the Determinants of Mortality and Neurosensory Sequelae

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • In-hospital mortality [ Time Frame: 30 days ]
    mortality in hospital at 30 days


Enrollment: 527
Study Start Date: March 2013
Study Completion Date: June 2017
Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with bacterial meningitis adults
Criteria

Inclusion Criteria:

  • Positive CSF culture and/or positive soluble antigens in CSF with or without a cell reaction
  • Positive PCR in CSF
  • Purpura fulminant (with or without positive CSF culture)
  • Positive PCR in blood and/or positive blood culture AND CSF cell reaction.

Exclusion Criteria:

  • Age less than 18 years old
  • Refusal to participate
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01730690


Locations
France
Assistance Publique des Hôpitaux de Paris
Paris, France
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Xavier duval APHP
  More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01730690     History of Changes
Other Study ID Numbers: CRC11040
NI11046 ( Other Identifier: APHP )
First Submitted: November 15, 2012
First Posted: November 21, 2012
Last Update Posted: July 5, 2017
Last Verified: July 2017

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Bacterial meningitis in adults
determinants of in-hospital mortality

Additional relevant MeSH terms:
Meningitis
Meningitis, Bacterial
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Bacterial Infections
Bacterial Infections
Central Nervous System Infections