Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06159270
Other study ID # Infectieux 1
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Recruiting NCT05568953 - An Experimental Medicine Decipher of a Minimum Correlate of Cellular Immunity Phase 2
Completed NCT04568889 - Minnesota COVID-19 Testing Project N/A
Completed NCT06063330 - Clinical Trial to Evaluate the Safety of RQ-01 in SARS-CoV-2 Positive Subjects Phase 1
Completed NCT01198925 - Assessment of the Optimal Dosing of Piperacillin-tazobactam in Intensive Care Unit Patients: Extended Versus Continuous Infusion Phase 4
Completed NCT05063812 - Performance of a Remote Monitoring Program for Patients Diagnosed With COVID-19
Not yet recruiting NCT03636711 - Antibiotic Stewardship in Infectious Disease Departement
Completed NCT03457688 - Effect of Prebiotic Fructans to Reduce Number of Febrile Infections in Children N/A
Completed NCT03241355 - Prebiotic Fructans on the Incidence of Acute Infectious Diseases in Children N/A
Terminated NCT05420077 - Safety and Immunogenicity of RVM-V001 in Healthy Individuals Previously Vaccinated With BNT162b2 and mRNA-1273 Phase 1
Completed NCT04084106 - Effects of Phenoximethylpenicillin, Amoxicillin and Amoxicillin-clavulanic Acid on the Gut Microbiota Phase 4
Recruiting NCT05013944 - AnovaOS Network Powered Patient Registry
Completed NCT03893279 - Perception of Smell and Taste During Antibiotic Treatment
Active, not recruiting NCT05619770 - Study to Evaluate Pharmacokinetics, Safety & Tolerability of 101-PGC-005 in Healthy, Adult, Human Subjects Phase 1
Completed NCT01772901 - Brief Influenza Vaccine Education to Pregnant Women N/A
Completed NCT05413772 - Temocillin in ESBL-Enterobacteriaceae Infections
Completed NCT04319328 - Is Cefazolin, Ceftazidime and Ciprofloxacin Dosing Optimal in Hemodialysis Patients?
Completed NCT04613271 - Efficacy and Safety of Favipiravir in Covid-19 Patients in Indonesia Phase 3
Completed NCT03239665 - Vaccination Education Through Pharmacists and Senior Centers (VEPSC) N/A
Completed NCT03224026 - Validation of a Proteomic Signature and Assessment of Viremia in Children With Fever Without Source
Not yet recruiting NCT06102070 - Genetic Susceptibility to Severe Infections