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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)

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ClinicalTrials.gov Identifier: NCT03912246
Recruitment Status : Recruiting
First Posted : April 11, 2019
Last Update Posted : June 7, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Infectious Disease Tropical Disease Biological: biological samples Procedure: lumbar puncture Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
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
Actual Study Start Date : April 27, 2009
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03912246


Contacts
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Contact: Marie-Noelle Ungeheuer, PhD +33 0140613581 marie-noelle.ungeheuer@pasteur.fr
Contact: Hélène Laude, PhD +33 0145688395 helene.laude@pasteur.fr

Locations
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France
Centre d'infectiologie, hopitale Necker Completed
Paris, France, 75015
Institut Pasteur Recruiting
Paris, France, 75015
Contact: Marie-Noelle Ungeheuer, PhD    0140613581    marie-noelle.ungeheuer@pasteur.fr   
Contact: Hélène Laude, PhD    0145688394    helene.laude@pasteur.fr   
Sponsors and Collaborators
Institut Pasteur

Publications:
Belizna C, Pregnolato F, Abad S, Alijotas-Reig J, Amital H, Amoura Z, Andreoli L, Andres E, Aouba A, Apras Bilgen S, Arnaud L, Bienvenu B, Bitsadze V, Blanco P, Blank M, Borghi MO, Caligaro A, Candrea E, Canti V, Chiche L, Chretien JM, Cohen Tervaert JW, Damian L, Delross T, Dernis E, Devreese K, Djokovic A, Esteve-Valverde E, Favaro M, Fassot C, Ferrer-Oliveras R, Godon A, Hamidou M, Hasan M, Henrion D, Imbert B, Jeandel PY, Jeannin P, Jego P, Jourde-Chiche N, Khizroeva J, Lambotte O, Landron C, Latino JO, Lazaro E, de Leeuw K, Le Gallou T, Kiliç L, Limper M, Loufrani L, Lubin R, Magy-Bertrand N, Mahe G, Makatsariya A, Martin T, Muchardt C, Nagy G, Omarjee L, Van Paasen P, Pernod G, Perrinet F, Pïres Rosa G, Pistorius MA, Ruffatti A, Said F, Saulnier P, Sene D, Sentilhes L, Shovman O, Sibilia J, Sinescu C, Stanisavljevic N, Stojanovich L, Tam LS, Tincani A, Tollis F, Udry S, Ungeheuer MN, Versini M, Cervera R, Meroni PL. HIBISCUS: Hydroxychloroquine for the secondary prevention of thrombotic and obstetrical events in primary antiphospholipid syndrome. Autoimmun Rev. 2018 Dec;17(12):1153-1168. doi: 10.1016/j.autrev.2018.05.012. Epub 2018 Oct 12. Review.

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Responsible Party: Institut Pasteur
ClinicalTrials.gov Identifier: NCT03912246     History of Changes
Other Study ID Numbers: 2008-16
DC-2008-68 ( Other Identifier: Institut Pasteur )
First Posted: April 11, 2019    Key Record Dates
Last Update Posted: June 7, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Institut Pasteur:
sample
diagnostic
Additional relevant MeSH terms:
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Communicable Diseases
Infection