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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 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: August 23, 2013
Last verified: August 2013
  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 ] [ Designated as safety issue: No ]
    mortality in hospital at 30 days


Estimated Enrollment: 450
Study Start Date: March 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: March 2017 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
France
Assistance Publique des Hôpitaux de Paris Recruiting
Paris, France
Contact: xavier duval    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: August 23, 2013
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
Bacterial Infections
Central Nervous System Bacterial Infections
Central Nervous System Diseases
Central Nervous System Infections
Nervous System Diseases

ClinicalTrials.gov processed this record on November 27, 2014