Clinical trial NCT03912246: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infectious Disease
Tropical Disease
Keywords: sample
diagnostic
Lead sponsor: Institut Pasteur
Sponsor class: INDUSTRY
First posted: 2019-04-11
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: development of new diagnostic methods
timeFrame: during all the study
Secondary outcomes:
measure: performance improvement
timeFrame: during all the study
Other outcomes:
Locations:
city: Paris
country: France
facility: Centre d'infectiologie, hopitale Necker
city: Paris
country: France
facility: Institut Pasteur
Study officials:
References:
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