MeningitisAdult-BMSNCT05062642
Validation of a Predictive Rule for the Diagnosis of Viral Meningitis in Adult Emergency Departments
An observational study of Meningitis, run by Centre Hospitalier le Mans at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meningitis
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 26 Aug 2021to 26 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Du Mans
Le Mans, 72000
Christelle JADEAU, 02 44 71 07 81, cjadeau@ch-lemans.fr
Jean-Christophe CALLAHAN, MD
About this study
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.
- Conditions
- Meningitis
- Keywords
- BMS score, Meningitis
- Medical subject headings
- Meningitis
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 month after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2021
- Study start26 Aug 2021
- Primary completion26 Aug 2022 (estimated)
- Study completion26 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MeningitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier le Mans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05062642
- Sponsor's protocol ID
- CHM-2020/S02/20
- Acronym
- Adult-BMS
- Status last verified
- Sep 2021
- First submitted
- 21 Sep 2021
- Last updated
- 24 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Predictive Rule for the Diagnosis of Viral Meningitis in Adult Emergency Departments
- ClinicalTrials.gov ID
- NCT05062642
- Acronym / sponsor ID
- Adult-BMS / CHM-2020/S02/20
- Conditions
- Meningitis
- Keywords
- BMS score, Meningitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Centre Hospitalier le MansUniversity, hospital or other
- Study start
- 26 Aug 2021 (actual)
- Primary completion
- 26 Aug 2022 (estimated)
- Study completion
- 26 Aug 2022 (estimated)
- First posted
- 30 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Meningitis, run by Centre Hospitalier le Mans at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christelle JADEAU (02 44 71 07 81, cjadeau@ch-lemans.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
External validation of the BMS score in a European adult population to exclude bacterial meningitis (time frame: 1 month after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2022.