Collection of Human Biological Samples for the Development and Validation of New Methods of Diagnosis and for the Realization of Expertises Diagnostics in the Field of Infectious Diseases and Tropical

Study Overview
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Brief Summary
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Direct constitution of collections from various samples taken on a prospective cohort of healthy volunteers, to prepare human biological samples of known characteristics (biochemical and serological in particular) and quality controlled.

Detailed Description
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Direct constitution of collection from various samples taken on a prospective cohort of healthy volunteers, to prepare human biological samples of known characteristics (biochemical and serological in particular) and quality controlled. This collection will allow, as a priority, a development stage, ie the establishment of the proof of concept of new diagnostic methods in the field of infectious and tropical diseases. There will be 2 cohorts (= arms) for this study: the main cohort of healthy volunteers and the N cohort, which will consist of patients with neuro-meningeal disease of infectious appearance and followed in specialized consultation.

Official Title
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Collection d'échantillons Biologiques Humains de Sujets Sains et Malades Pour la Mise au Point et la Validation de Nouvelles méthodes de Diagnostic et Pour la réalisation d'Expertises Dans le Domaine Des Maladies Infectieuses et Tropicales

Conditions
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Infectious Disease, Tropical Disease

Intervention / Treatment
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* Biological: biological samples
* Procedure: lumbar puncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: major subject affiliated or benefiting from social security having signed the information and consent form negative HIV and HCV serology and negative HBV or vaccine serology (or old healed infection profile) for cohort N: neuromeningeal infection during dianostic exploration Exclusion Criteria: Volunteers with a severe or chronic pathology significantly disturbing one or more bio-clinical parameters and / or requiring the regular intake of certain drugs (anti-inflammatories or corticosteroids for example). Woman whose pregnancy is known during the visit. Acute infection within 15 days or taking antiviral, antibiotic, antifungal or antiparasitic drugs in the last 15 days. Subject participating in a biomedical research or in a period of exclusion of a biomedical research. When monitoring O +, AB +, A + and B + blood group whose erythrocyte base is kept for CEPIA research, in case of antimalarial (travel), a minimum of 5 half-lives after the last dose of antimalaria.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy volunteers<br>Human biological samples: whole blood (serum or plasma, PBMCs, red blood cells), urine, feces, saliva, tears, mouth and skin swabs. Bio-clinical data : adjusted to the purpose of the searches will be collected | Biological: biological samples<br>* collection of blood, urine, saliva, stool, skin and mouth swabs, tears<br>|
| Experimental: Patients with neuro-meningeal infection<br>Human biological samples: Whole blood (serum or plasma, PBMCs, red blood cells), urine, feces, saliva, tears, mouth and skin swabs. Extended collection of CSF Bio-clinical data : adjusted to the purpose of the searches will be collected | Biological: biological samples<br>* collection of blood, urine, saliva, stool, skin and mouth swabs, tears<br>Procedure: lumbar puncture<br>* collection of cerebrospinal fluid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| development of new diagnostic methods | This collection will allow, as a priority, a first stage of development, that is to say the completion of the proof of concept of new diagnostic methods in the field of infectious and tropical diseases. | during all the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| performance improvement | In a second step, the collection will be able to improve the essential performances (sensitivity and specificity) of the methods to the study compared to the existing methods: speed, simplicity (molecular methods, etc) and cost; and may also uncover new non-infectious biomarkers. | during all the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sample, diagnostic