Etiology of Orphan Community-based Meningitis and Meningo-encephalitis. (MENINGITE)
Primary Purpose
Community-based Meningitis, Meningo-encephalitis
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Pharyngeal swab
Sponsored by
About this trial
This is an interventional diagnostic trial for Community-based Meningitis
Eligibility Criteria
Inclusion Criteria:
- Patient is aged more than 18 years old.
- Patient with clinical meningitis or meningo-encephalitis with community transmission.
- Patient with a prescription of microbiological diagnosis of meningitis or meningo-encephalitis.
- Patient who do not declined to have his medical records reviewed for research
- Patient with health insurance
Exclusion Criteria:
- Minor Patient (age <18 years)
- Pregnant woman, parturient or breastfeeding
- Adult Patient under guardianship
- Patient deprived of liberty under court order
- Patient vital in emergency.
Sites / Locations
- Assistance Publique Hopitaux de MarseilleRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patient with clinical meningitis or meningo-encephalitis
Arm Description
Outcomes
Primary Outcome Measures
Percentage of patients with established etiological diagnosis of community based meningitis or meningo-encephalitis
Secondary Outcome Measures
Full Information
NCT ID
NCT02868593
First Posted
August 11, 2016
Last Updated
August 11, 2016
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT02868593
Brief Title
Etiology of Orphan Community-based Meningitis and Meningo-encephalitis.
Acronym
MENINGITE
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
January 2017 (Anticipated)
Study Completion Date
June 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary purpose of this study is to assess the contribution of a non-invasive sampling (pharyngeal swab) in the diagnosis of community based meningitis or meningo-encephalitis.
Detailed Description
Community-based meningitis and meningo-encephalitis are defined by the presence of more than 10 leukocytes per mL of cerebrospinal fluid (CSF), eventually reported to the number of red blood cells. They can be associated with encephalitis, defined by cerebral or cerebellar dysfunction in the case of the transmission. The evolution includes death, what makes the seriousness of this clinical situation. However the diagnostic performance of meningitis and meningo-encephalitis in a patient without contact with a care structure is less than 25% resulting in empirical support in half of the patients. Indeed, the microbiological diagnosis of meningitis and transmission target currently only five pathogens including HIV positive resulted in a significant change to support the patient in three areas, decision of hospitalization, decision of isolation and antibiotic or antiviral treatment decision. A weekly epidemiological monitoring of the microbiological diagnosis of meningitis and meningo-encephalitis has enabled us to see a mismatch between a curve of requests for analyses and a flat curve of produced diagnoses. This discrepancy is interpreted as indicating a community outbreak of meningitis or meningo-encephalitis non-diagnosed by routine methods, called orphan meningitis or orphan meningo-encephalitis. On this observation, our research project is to improve the performance of the etiological diagnosis of community-based meningitis or meningo-encephalitis. To do this, we will evaluate the diagnostic performance of an advanced technique, using a non-invasive sample, the pharyngeal swab from the patient, to find micro-organisms that are not part of the commensal flora of the pharynx and who are responsible for undetected in routine meningitis. Indeed the main pathogens and meningitis (enterovirus, pneumococcus, meningococcus) transmission give a pharyngeal carriage before being responsible for meningitis or meningo-encephalitis. These bacteria are Coxiella burnetii, Bartonella spp., Tropheryma whipplei, Leptospira spp. and Borrelia spp.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Community-based Meningitis, Meningo-encephalitis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1800 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patient with clinical meningitis or meningo-encephalitis
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Pharyngeal swab
Primary Outcome Measure Information:
Title
Percentage of patients with established etiological diagnosis of community based meningitis or meningo-encephalitis
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient is aged more than 18 years old.
Patient with clinical meningitis or meningo-encephalitis with community transmission.
Patient with a prescription of microbiological diagnosis of meningitis or meningo-encephalitis.
Patient who do not declined to have his medical records reviewed for research
Patient with health insurance
Exclusion Criteria:
Minor Patient (age <18 years)
Pregnant woman, parturient or breastfeeding
Adult Patient under guardianship
Patient deprived of liberty under court order
Patient vital in emergency.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michel DRANCOURT
Phone
04 91 38 55 19
Ext
+33
Email
michel.drancourt@ap-hm.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandra GIULIANI
Phone
04 91 38 28 70
Ext
+33
Email
alexandra.giuliani@ap-hm.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine GEINDRE
Organizational Affiliation
Assistance Publique Hôpitaux de Marseille
Official's Role
Study Director
Facility Information:
Facility Name
Assistance Publique Hopitaux de Marseille
City
Marseille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MICHEL DRANCOURT
Email
michel.drancourt@ap-hm.fr
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Etiology of Orphan Community-based Meningitis and Meningo-encephalitis.
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