- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02868593
Etiology of Orphan Community-based Meningitis and Meningo-encephalitis. (MENINGITE)
August 11, 2016 updated by: Assistance Publique Hopitaux De Marseille
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
1800
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
- Recruiting
- Assistance Publique Hopitaux de Marseille
-
Contact:
- MICHEL DRANCOURT
- Email: michel.drancourt@ap-hm.fr
-
-
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
Description
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.
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: Patient with clinical meningitis or meningo-encephalitis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of patients with established etiological diagnosis of community based meningitis or meningo-encephalitis
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
January 1, 2014
Primary Completion (Anticipated)
January 1, 2017
Study Completion (Anticipated)
June 1, 2017
Study Registration Dates
First Submitted
August 11, 2016
First Submitted That Met QC Criteria
August 11, 2016
First Posted (Estimate)
August 16, 2016
Study Record Updates
Last Update Posted (Estimate)
August 16, 2016
Last Update Submitted That Met QC Criteria
August 11, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013-47
- 2013-A01538-37 (Other Identifier: ANSM)
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.
Clinical Trials on Meningo-encephalitis
-
National Institute of Allergy and Infectious Diseases...CompletedAlphavirus Infections | Eastern Equine Encephalitis | Venezuelan Equine Encephalitis | Western Equine EncephalitisUnited States
-
Medical University of ViennaAustrian Science Fund (FWF)CompletedTick Borne EncephalitisAustria
-
PfizerCompletedTick-borne Encephalitis (TBE)Poland
-
PATHCompletedEncephalitis, Japanese BPhilippines
-
Valneva Austria GmbHCompleted
-
Valneva Austria GmbHCompletedEncephalitisUnited States, Australia, Denmark, Germany, Sweden
-
National Institute of Hygiene and Epidemiology,...Ministry of Health, Vietnam; Ministry of Science and Technology, VietnamCompleted
-
National Institute of Hygiene and Epidemiology,...Ministry of Health, Vietnam; Ministry of Science and Technology, VietnamCompleted
-
Sanofi Pasteur, a Sanofi CompanyCompleted
-
Valneva Austria GmbHCompleted
Clinical Trials on Pharyngeal swab
-
Assistance Publique Hopitaux De MarseilleCompleted
-
French National Agency for Research on AIDS and...CompletedHIV Infections | InfluenzaFrance
-
Wissenschaftliches Institut Bethanien e.VCompleted
-
Assistance Publique Hopitaux De MarseilleCompletedAcute Respiratory InfectionFrance
-
Centre Hospitalier Universitaire VaudoisCompletedLower Resp Tract InfectionSwitzerland
-
University Children's Hospital, ZurichCompletedDiagnosis | Childhood Pneumonia | Mycoplasma Pneumonia | Antibody-secreting Cells | Enzyme-linked Immunospot (ELISpot)
-
Medical College of WisconsinRecruiting
-
Newcastle-upon-Tyne Hospitals NHS TrustUnknownRespiratory Distress Syndrome in Premature Infants | Extreme Prematurity - Less Than 28 WeeksUnited Kingdom