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 (Diagmicoll)

Pasteur Institute

Status: Completed

Conditions: Tropical Disease; Infectious Disease

Treatments: Procedure: lumbar puncture; Biological: biological samples

Study type: Interventional

Funder types: Industry

Identifiers

NCT03912246

DC-2008-68 (Other Identifier)

2008-16

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 800 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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800 participants in 2 patient groups

Healthy volunteers

Experimental group

Description:

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

Treatment:

Biological: biological samples

Patients with neuro-meningeal infection

Experimental group

Description:

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

Treatment:

Biological: biological samples

Procedure: lumbar puncture