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

Not Applicable

Completed

• Conditions: Tropical Disease; Infectious Disease
• Interventions: Biological: biological samples; Procedure: lumbar puncture

• Registration Number: NCT03912246
• Lead Sponsor: Institut Pasteur

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.

Study Timeline

• Study Start: 2009-04-27
• Study First Submitted: 2019-04-10
• Study First Submitted QC: 2019-04-10
• Study First Posted: 2019-04-11
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2023-06
• Last Update Submitted: 2023-07-06
• Last Update Posted: 2023-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 800

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Patients with neuro-meningeal infection	lumbar puncture	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
Patients with neuro-meningeal infection	biological samples	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
Healthy volunteers	biological samples	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

Primary Outcome Measures

Name	Time	Method
development of new diagnostic methods	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 Outcome Measures

Name	Time	Method
performance improvement	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.

Trial Locations

Locations (2)

Institut Pasteur; 🇫🇷 Paris, France

Centre d'infectiologie, hopitale Necker; 🇫🇷 Paris, France