Clinical trial

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

Name

2008-16

Description

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.

Trial arms

Trial start

2009-04-27

Estimated PCD

2021-12-31

Trial end

2021-12-31

Status

Completed

Treatment

biological samples

collection of blood, urine, saliva, stool, skin and mouth swabs, tears

Arms:

Healthy volunteers, Patients with neuro-meningeal infection

lumbar puncture

collection of cerebrospinal fluid

Arms:

Patients with neuro-meningeal infection

Size

800

Primary endpoint

development of new diagnostic methods

during all the study

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'FACTORIAL', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 800, 'type': 'ACTUAL'}}

Updated at

2023-07-07

1 organization

1 product

2 indications

Organization

Product

Indication

Indication