NCT05062642

Brief Summary

Meningitis is the development of an inflammatory reaction in the meningeal space, most often of infectious origin. Many pathogens can cause meningitis, the severity of which varies greatly. Patients presenting with a febrile meningeal syndrome are most often managed in the emergency room, where the challenge for physicians is to quickly differentiate bacterial and viral meningitis. Viral meningitis is the most common, with enterovirus meningitis having a classically excellent prognosis. Bacterial meningitis is less frequent but more serious.The current public health objective is to save antibiotics. Investigator hypothesizes that the BMS score can be used to exclude bacterial meningitis in the emergency department in an adult European population of patients with suspected bacterial meningitis.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 26, 2021

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

September 21, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 30, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 26, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 26, 2022

Completed
Last Updated

January 24, 2022

Status Verified

September 1, 2021

Enrollment Period

1 year

First QC Date

September 21, 2021

Last Update Submit

January 7, 2022

Conditions

Keywords

BMS scoreMeningitis

Outcome Measures

Primary Outcomes (1)

  • External validation of the BMS score in a European adult population to exclude bacterial meningitis

    Validation was measured by comparaison between BMS score and the diagnosis retained from the data collected in the file

    1 month after inclusion

Eligibility Criteria

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

The study population will be extracted from the population having consulted the Adult Emergency Departments of the Le Mans Hospital, the Angers and Nantes University Hospitals and the Beaujon University Hospital between January 1, 2009 and December 31, 2020 and for whom a lumbar puncture will have been performed for suspected meningitis.

You may qualify if:

  • Patient admitted to the Adult Emergency Department of CH Le Mans,CHU Angers, CHU Nantes or Beaujon Hospital.
  • Over 18 years old
  • Having had a lumbar puncture during their stay in the Adult Emergency Department
  • Having had a diagnosis of meningitis defined as a pleocytosis ≥ 5leukocytes/mm3 after correction with CSF red blood cells at a standardized ratio of 500/1.

You may not qualify if:

  • Immunosuppression from any cause
  • Presence of petechiae or purpura
  • History of recent neurosurgery or head trauma
  • Other associated bacterial infection
  • Inability to collect information for the BMS score calculation or primary endpoint (e.g., transfer to another facility)
  • Minor or adult patient under guardianship or protection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Du Mans

Le Mans, 72000, France

RECRUITING

MeSH Terms

Conditions

Meningitis

Condition Hierarchy (Ancestors)

Neuroinflammatory DiseasesNervous System Diseases

Central Study Contacts

Christelle JADEAU

CONTACT

Jean-Christophe CALLAHAN, MD

CONTACT

Study Design

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

Study Record Dates

First Submitted

September 21, 2021

First Posted

September 30, 2021

Study Start

August 26, 2021

Primary Completion

August 26, 2022

Study Completion

August 26, 2022

Last Updated

January 24, 2022

Record last verified: 2021-09

Locations