Infectious Prospective Collection for Biological Analysis
NCT ID: NCT06159270
Last Updated: 2023-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
22870 participants
OBSERVATIONAL
2019-05-18
2025-05-18
Brief Summary
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It is in this context that CerbaXpert took the initiative to set up this research project for the collection of prospective biological samples and their analysis. It transcribes both a process of continuous improvement but also scientific development, making it possible to provide new and/or complementary data in order to improve the operation of automated systems and their reagents within medical biology laboratories. These data obtained in current practice via this study will also be compared with the technical information provided by the manufacturers of the reagents and their automatic devices.
Detailed Description
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This protocol does not include special procedure for allocation or differential treatment for the subjects included: there is neither randomization or treatment assigned to people participating in the study.
The subjects recruited will be within several survey sites spread across the national territory: the Cerballiance medical biology laboratories, belonging to the Cerba HealthCare group. Some clinical sites can be managed via a centralized collection site, where a person is designated as principal investigator after qualification by the promoter and authorization from the Committee of Protection of People.
Information relating to age, sex, date and place of sampling, sample population of each subject (general patients, hospitalized patients, pregnant women, dialysis patients or patients known positive for one of the infectious agents targeted by this research protocol) will be also varied. Relevant medical data may also be compiled:
1. the genotype of HAV, B, C, D and E, HIV, HBV (if available);
2. the stage of the disease (acute, chronic, cured);
3. concomitant treatments linked to the pathology (if available) or which may interfere with the planned analysis.
4. data relating to the participant's lifestyle.
5. date of onset of symptoms, date of PCR test if applicable, vaccination status, date of vaccination, name of vaccine, number of injections, batch number of vaccine.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort of patients presenting infectious diseases
Blood sample
Venuous blood sampling
Interventions
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Blood sample
Venuous blood sampling
Eligibility Criteria
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Inclusion Criteria
* Hospitalized patients
* Pregnant women (all comers)
* Subjects on dialysis
* Known subjects positive for targeted pathogens
Exclusion Criteria
* Subject having received medication or treatment experimental or investigational during the last four weeks before collection
* Person subject to a judicial safeguard measure
* Person not affiliated to the Social Security system and not not having social security coverage
18 Years
88 Years
ALL
No
Sponsors
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CerbaXpert
OTHER
Responsible Party
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Principal Investigators
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Barbara Pernicni, Dr
Role: STUDY_DIRECTOR
Cerba Xpert
Locations
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Cerba Xpert
Saint-Ouen-l'Aumône, , France
Countries
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Central Contacts
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Facility Contacts
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Barbara Perniconi, Dr
Role: primary
Other Identifiers
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Infectieux 1
Identifier Type: -
Identifier Source: org_study_id