Validation of a Predictive Rule for the Diagnosis of Viral Meningitis in Adult Emergency Departments (Adult-BMS)

January 7, 2022 updated by: Centre Hospitalier le Mans

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Le Mans, France, 72000
        • Recruiting
        • Centre Hospitalier du Mans

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Antibiotic therapy within 72 hours of inclusion
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
External validation of the BMS score in a European adult population to exclude bacterial meningitis
Time Frame: 1 month after inclusion
Validation was measured by comparaison between BMS score and the diagnosis retained from the data collected in the file
1 month after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier le Mans

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 26, 2021

Primary Completion (Anticipated)

August 26, 2022

Study Completion (Anticipated)

August 26, 2022

Study Registration Dates

First Submitted

September 21, 2021

First Submitted That Met QC Criteria

September 21, 2021

First Posted (Actual)

September 30, 2021

Study Record Updates

Last Update Posted (Actual)

January 24, 2022

Last Update Submitted That Met QC Criteria

January 7, 2022

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHM-2020/S02/20

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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