Validation of a Predictive Rule for the Diagnosis of Viral Meningitis in Adult Emergency Departments

Meningitis Clinical Trial

— Adult-BMS  

Official title:

Validation of a Predictive Rule for the Diagnosis of Viral Meningitis in Adult Emergency Departments

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05062642
• Other study ID #: CHM-2020/S02/20
• Status: Recruiting
• Start date: August 26, 2021
• Est. completion date: August 26, 2022

Study information

• Verified date: September 2021
• Source: Centre Hospitalier le Mans
• Contact: Christelle JADEAU
• Phone: 02 44 71 07 81
• Email: cjadeau[@]ch-lemans.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: August 26, 2022
• Est. primary completion date: August 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Meningitis

Locations

Country	Name	City	State
France	Centre Hospitalier Du Mans	Le Mans

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier le Mans

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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