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

This study is not yet open for participant recruitment.
Verified October 2012 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01730690
First received: November 15, 2012
Last updated: November 20, 2012
Last verified: October 2012
History of Changes
  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:

MedlinePlus related topics: Meningitis
U.S. FDA Resources

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

Primary Outcome Measures:
  • In-hospital mortality [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    mortality in hospital at 30 days


Estimated Enrollment: 450
Study Start Date: November 2012
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01730690

Contacts
Contact: Xavier Duval (0) 1 40 25 71 48 ext +33 xavier.duval@bch.aphp.fr

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

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01730690     History of Changes
Other Study ID Numbers: CRC11040, NI11046
Study First Received: November 15, 2012
Last Updated: November 20, 2012
Health Authority: France: French Data Protection Authority

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 Infections
Central Nervous System Diseases
 Nervous System Diseases
Central Nervous System Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on May 23, 2013