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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)

Primary Purpose

Infectious Disease, Tropical Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
biological samples
lumbar puncture
Sponsored by
Institut Pasteur
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Infectious Disease focused on measuring sample, diagnostic

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Centre d'infectiologie, hopitale Necker
  • Institut Pasteur

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Healthy volunteers

Patients with neuro-meningeal infection

Arm 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

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

Outcomes

Primary Outcome Measures

development of new diagnostic methods
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 Outcome Measures

performance improvement
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.

Full Information

First Posted
April 10, 2019
Last Updated
July 6, 2023
Sponsor
Institut Pasteur
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1. Study Identification

Unique Protocol Identification Number
NCT03912246
Brief Title
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
Acronym
Diagmicoll
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
April 27, 2009 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Pasteur

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infectious Disease, Tropical Disease
Keywords
sample, diagnostic

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
800 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy volunteers
Arm Type
Experimental
Arm 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
Arm Title
Patients with neuro-meningeal infection
Arm Type
Experimental
Arm 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
Intervention Type
Biological
Intervention Name(s)
biological samples
Intervention Description
collection of blood, urine, saliva, stool, skin and mouth swabs, tears
Intervention Type
Procedure
Intervention Name(s)
lumbar puncture
Intervention Description
collection of cerebrospinal fluid
Primary Outcome Measure Information:
Title
development of new diagnostic methods
Description
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.
Time Frame
during all the study
Secondary Outcome Measure Information:
Title
performance improvement
Description
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.
Time Frame
during all the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Centre d'infectiologie, hopitale Necker
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Institut Pasteur
City
Paris
ZIP/Postal Code
75015
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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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

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