- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02858661
Improving the Diagnosis of Meningitis in Emergency Rooms
April 20, 2023 updated by: Assistance Publique Hopitaux De Marseille
A point-of-care laboratory (POC) was set at North Hospital, Marseille, France for the diagnosis in less than two hours of meningitis caused by known pathogens, close to the reception of Emergency service.
In this instance 30% of patients have no etiological diagnosis after the POC diarrhoea tests .
This lab has discovered over 200 new species of bacteria in humans, including vector bacteria and opened the field of large Deoxyribonucleic Acid (DNA ) viruses.
Also, the laboratory of emerging viruses discovered many Ribonucleic Acid (RNA) viruses transmitted by arthropods.
Based on this collection of new pathogens described in POC laboratory, this study proposes to expand the etiological diagnosis strategy of meningitis after POC test.
Study Overview
Study Type
Interventional
Enrollment (Actual)
109
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Marseille, France, 13354
- Assistance Publique Hopitaux de Marseille
-
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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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patient admitted at hospital for meningitis requiring, for the emergency physician, a microbiological examination with a "POC meningitis kit."
- Patient who has freely signed the informed written consent
- Patient affiliated to a social security scheme
Exclusion Criteria:
- Pregnant woman, parturient or nursing
- Adult patient under guardianship
- Patient deprived of liberty under court order
- Patient refusing or unable to sign the informed consent form.
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
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Patients diagnosed with clinical meningitis
Patients admitted in emergency rooms for clinical meningitis, for which a nasopharyngeal swab will be performed in order to confirm the etiological diagnosis of meningitis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Percentage of patients admitted with a meningitis with a confirmed etiological diagnosis
Time Frame: 1 day
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
March 30, 2013
Primary Completion (Actual)
February 8, 2019
Study Completion (Actual)
October 27, 2022
Study Registration Dates
First Submitted
July 29, 2016
First Submitted That Met QC Criteria
August 3, 2016
First Posted (Estimate)
August 8, 2016
Study Record Updates
Last Update Posted (Actual)
April 21, 2023
Last Update Submitted That Met QC Criteria
April 20, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2012-45
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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