NCT01730690

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
527

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 21, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

July 5, 2017

Status Verified

July 1, 2017

Enrollment Period

4.3 years

First QC Date

November 15, 2012

Last Update Submit

July 3, 2017

Conditions

Meningitis, Bacterial

Keywords

Bacterial meningitis in adultsdeterminants of in-hospital mortality

Outcome Measures

Primary Outcomes (1)

  • In-hospital mortality

    mortality in hospital at 30 days

    30 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with bacterial meningitis adults

You may qualify if:

  • 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.

You may not qualify if:

  • Age less than 18 years old
  • Refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique des Hôpitaux de Paris

Paris, France

Location

Related Publications (6)

  • Van RN, Tubiana S, De Broucker T, Cedric J, Roy C, Meyohas MC, Prazuck T, Chirouze C, Hoen B, Duval X, Revest M; COMBAT study group. Persistent headaches one year after bacterial meningitis: prevalence, determinants and impact on quality of life. Eur J Clin Microbiol Infect Dis. 2023 Dec;42(12):1459-1467. doi: 10.1007/s10096-023-04673-y. Epub 2023 Oct 23.

    PMID: 37867184DERIVED

  • Della Vecchia C, Ebah JV, Tubiana S, Guimard T, Piroth L, Jaffuel S, Gorenne I, Mourvillier B, Hoen B, Duval X, Preau M. Mid-term health-related quality of life in community-acquired bacterial meningitis survivors; the COMBAT study. PLoS One. 2023 Mar 23;18(3):e0281544. doi: 10.1371/journal.pone.0281544. eCollection 2023.

    PMID: 36952472DERIVED

  • Akroum S, Tubiana S, de Broucker T, Dournon N, Varon E, Ploy MC, Mourvillier B, Oziol E, Lacassin F, Laurichesse H, Hoen B, Duval X, Burdet C; and the COMBAT study group. Long-term neuro-functional disability in adult patients with community-acquired bacterial meningitis. Infection. 2022 Oct;50(5):1363-1372. doi: 10.1007/s15010-022-01855-2. Epub 2022 Jun 3.

    PMID: 35657529DERIVED

  • Duval X, Taha MK, Lamaury I, Escaut L, Gueit I, Manchon P, Tubiana S, Hoen B; COMBAT study group. One-Year Sequelae and Quality of Life in Adults with Meningococcal Meningitis: Lessons from the COMBAT Multicentre Prospective Study. Adv Ther. 2022 Jun;39(6):3031-3041. doi: 10.1007/s12325-022-02149-7. Epub 2022 Apr 28.

    PMID: 35484469DERIVED

  • Benadji A, Duval X, Danis K, Hoen B, Page B, Beraud G, Vernet-Garnier V, Strady C, Brieu N, Maulin L, Roy C, Ploy MC, Gaillat J, Varon E, Tubiana S; COMBAT Study Group; SIIP Study Group. Relationship between serotypes, disease characteristics and 30-day mortality in adults with invasive pneumococcal disease. Infection. 2022 Feb;50(1):223-233. doi: 10.1007/s15010-021-01688-5. Epub 2021 Sep 1.

    PMID: 34468953DERIVED

  • Tubiana S, Varon E, Biron C, Ploy MC, Mourvillier B, Taha MK, Revest M, Poyart C, Martin-Blondel G, Lecuit M, Cua E, Pasquet B, Preau M, Hoen B, Duval X; COMBAT study group. Community-acquired bacterial meningitis in adults: in-hospital prognosis, long-term disability and determinants of outcome in a multicentre prospective cohort. Clin Microbiol Infect. 2020 Sep;26(9):1192-1200. doi: 10.1016/j.cmi.2019.12.020. Epub 2020 Jan 10.

    PMID: 31927117DERIVED

MeSH Terms

Conditions

Meningitis, Bacterial

Condition Hierarchy (Ancestors)

Central Nervous System Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsCentral Nervous System InfectionsCentral Nervous System DiseasesNervous System DiseasesMeningitisNeuroinflammatory Diseases

Study Officials

  • Xavier duval

    APHP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2012

First Posted

November 21, 2012

Study Start

March 1, 2013

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

July 5, 2017

Record last verified: 2017-07

Locations

FR(1)