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

Meningo-encephalitis Clinical Trial

— MENINGITE  

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02868593
• Other study ID #: 2013-47
• Secondary ID: 2013-A01538-37
• Status: Recruiting
• Phase: N/A
• First received: August 11, 2016
• Last updated: August 11, 2016
• Start date: January 2014
• Est. completion date: June 2017

Study information

• Verified date: August 2016
• Source: Assistance Publique Hopitaux De Marseille
• Contact: Michel DRANCOURT
• Phone: 04 91 38 55 19
• Email: michel.drancourt[@]ap-hm.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1800
• Est. completion date: June 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Community-based Meningitis
• Encephalitis
• Meningitis
• Meningo-encephalitis
• Meningoencephalitis

Intervention

Other:
• Pharyngeal swab

Locations

Country	Name	City	State
France	Assistance Publique Hopitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with established etiological diagnosis of community based meningitis or meningo-encephalitis		1 day	No