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)

July 6, 2023 updated by: Institut Pasteur

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

800

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75015
        • Institut Pasteur
      • Paris, France, 75015
        • Centre d'infectiologie, hopitale Necker

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Healthy volunteers

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
collection of blood, urine, saliva, stool, skin and mouth swabs, tears
Experimental: Patients with neuro-meningeal infection

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
collection of blood, urine, saliva, stool, skin and mouth swabs, tears
Procedure: lumbar puncture
collection of cerebrospinal fluid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
during all the study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
performance improvement
Time Frame: during all the study
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Pasteur

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 27, 2009

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

April 10, 2019

First Submitted That Met QC Criteria

April 10, 2019

First Posted (Actual)

April 11, 2019

Study Record Updates

Last Update Posted (Actual)

July 7, 2023

Last Update Submitted That Met QC Criteria

July 6, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008-16
  • DC-2008-68 (Other Identifier: Institut Pasteur)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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