Etiology of Orphan Community-based Meningitis and Meningo-encephalitis.

NCT ID: NCT02868593

Last Updated: 2016-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2017-06-30

Brief Summary

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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

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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.

Conditions

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Community-based Meningitis Meningo-encephalitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patient with clinical meningitis or meningo-encephalitis

Group Type EXPERIMENTAL

Pharyngeal swab

Intervention Type OTHER

Interventions

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Pharyngeal swab

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Catherine GEINDRE

Role: STUDY_DIRECTOR

Assistance Publique Hôpitaux de Marseille

Locations

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Assistance Publique Hopitaux de Marseille

Marseille, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Michel DRANCOURT

Role: CONTACT

04 91 38 55 19 ext. +33

Alexandra GIULIANI

Role: CONTACT

04 91 38 28 70 ext. +33

Facility Contacts

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MICHEL DRANCOURT

Role: primary

Other Identifiers

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2013-A01538-37

Identifier Type: OTHER

Identifier Source: secondary_id

2013-47

Identifier Type: -

Identifier Source: org_study_id

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