Infectious Prospective Collection for Biological Analysis

Infectious Disease Clinical Trial

— Infectieux1  

Official title:

Collection of Prospective Biological Samples for Biological Analysis in Current Clinical Practice

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06159270
• Other study ID #: Infectieux 1
• Status: Recruiting
• Start date: May 18, 2019
• Est. completion date: May 18, 2025

Study information

• Verified date: December 2023
• Source: CerbaXpert
• Contact: Barbara Perniconi, Dr
• Phone: 0142657831
• Email: bperniconi[@]cerbaresearch.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The increase in activity within medical biology laboratories linked to the arrival of new markers (in cardiology, oncology, infectious diseases, etc.) and the acceleration of technical progress have created a prominent place for automated systems and their reagent kits within these establishments.

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.

Description:

This research protocol is a prospective multicenter collection of biological samples for evaluation of reagents and automated systems on the following parameters: HAV, B, C, D and E, HIV, HBV, EBV, CMV, VZV, HPV, HSV, polyomavirus family, Chlamydia Trachomatis, Neisseria gonorrhoeae, Mycoplasma genitalium, Trichomonas vaginalis, Treponema pallidum, Zika virus, dengue fever, chikungunya virus, influenza virus, Mycobacterium tuberculosis bacteria, parasite responsible for toxoplasmosis, malaria, rubella virus, Lyme borreliosis Sars-CoV-2 virus responsible for Covid-19 disease, bacteria responsible for leptospirosis and salmonellosis, the pathogens responsible for sepsis (viruses, bacteria or fungus) and finally the Poxiviridae family. This research is categorized as Research Involving Human Person level 3 (RIPH 3), that is to say non-interventional, carried out in current medical practice. Recruitment will include a maximum of 22870 samples belonging to the following groups: population general (ambulatory patients, hospitalized patients, pregnant women, dialysis patients) and known population carrying the desired infectious agent.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 22870
• Est. completion date: May 18, 2025
• Est. primary completion date: May 18, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 88 Years

Eligibility

Inclusion Criteria:

• All-comers clinical subjects (ambulatory)

• Hospitalized patients

• Pregnant women (all comers)

• Subjects on dialysis

• Known subjects positive for targeted pathogens

Exclusion Criteria:

• Subject having already participated in this protocol within 15 days previous ones.

• 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

• Person not meeting the inclusion criteria

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Infectious Disease

Intervention

Other:
• Blood sample
Venuous blood sampling

Locations

Country	Name	City	State
France	Cerba Xpert	Saint-Ouen-l'Aumône

Sponsors (1)

Lead Sponsor	Collaborator
CerbaXpert

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of clinical and analytical performance of In vitro diagnostic tests used in routine care for infectious diseases by using ROC curve	Venipuncture sampling; Blood sampling by capillary action; Swab sampling; Salivary samples; Urine sampling; Dried Blood Spot (DBS) sampling	24 months