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Clinical Trials/NCT03912246
NCT03912246
Completed
Not Applicable

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

Institut Pasteur2 sites in 1 country800 target enrollmentApril 27, 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Infectious Disease
Sponsor
Institut Pasteur
Enrollment
800
Locations
2
Primary Endpoint
development of new diagnostic methods
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 27, 2009
End Date
December 31, 2021
Last Updated
2 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

development of new diagnostic methods

Time Frame: during all the study

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.

Secondary Outcomes

  • performance improvement(during all the study)

Study Sites (2)

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