Infectious DiseaseInfectieux1NCT06159270
Infectious Prospective Collection for Biological Analysis
An observational study of Infectious Disease, run by CerbaXpert at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 88 years
- Conditions the study is for
- Infectious Disease
- What is being tested?
- Blood sample
- How many people
- 22,870 participants
- Where
- 1 siteFrance
- Study dates
- 18 May 2019to 18 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Man or woman, aged 18 to 88, coming for an analysis biological as part of routine care, for prevention, screening or the monitoring of at least one of the pathogens targeted or benefiting of a teleconsultation and accepting additional samples carried out by a healthcare professional and, where applicable, capable of allow a maximum of 21 ml of whole blood or two swabs additional and able to give consent
Who may be able to join
- All-comers clinical subjects (ambulatory)
- Hospitalized patients
- Pregnant women (all comers)
- Subjects on dialysis
- Known subjects positive for targeted pathogens
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Cerba Xpert
Saint-Ouen-l'Aumône
Barbara Perniconi, Dr, 0142161001, bperniconi@cerbaresearch.com
About this study
Official title: Collection of Prospective Biological Samples for Biological Analysis in Current Clinical Practice
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.
Read the detailed 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:
- the genotype of HAV, B, C, D and E, HIV, HBV (if available);
- the stage of the disease (acute, chronic, cured);
- concomitant treatments linked to the pathology (if available) or which may interfere with the planned analysis.
- data relating to the participant's lifestyle.
- 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
- Infectious Disease
- Being tested
- Blood sample
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleOther
Venuous blood sampling
| Study group | Role | What they receive |
|---|---|---|
| Cohort of patients presenting infectious diseases | Not described Receives: Other: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start18 May 2019
- Primary completion18 May 2025 (estimated)
- Study completion18 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infectious DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 22,870 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CerbaXpert
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Barbara Pernicni, Dr, Study director, Cerba Xpert
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06159270
- Sponsor's protocol ID
- Infectieux 1
- Acronym
- Infectieux1
- Status last verified
- Dec 2023
- First submitted
- 17 Nov 2023
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Prospective Biological Samples for Biological Analysis in Current Clinical Practice
- ClinicalTrials.gov ID
- NCT06159270
- Acronym / sponsor ID
- Infectieux1 / Infectieux 1
- Conditions
- Infectious Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 22,870 participants (estimated)
- Lead sponsor
- CerbaXpertUniversity, hospital or other
- Study start
- 18 May 2019 (actual)
- Primary completion
- 18 May 2025 (estimated)
- Study completion
- 18 May 2025 (estimated)
- First posted
- 6 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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:
- the genotype of HAV, B, C, D and E, HIV, HBV (if available);
- the stage of the disease (acute, chronic, cured);
- concomitant treatments linked to the pathology (if available) or which may interfere with the planned analysis.
- data relating to the participant's lifestyle.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort of patients presenting infectious diseases | – | Other: Blood sample |
Who may qualify
- Ages
- 18 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Man or woman, aged 18 to 88, coming for an analysis biological as part of routine care, for prevention, screening or the monitoring of at least one of the pathogens targeted or benefiting of a teleconsultation and accepting additional samples carried out by a healthcare professional and, where applicable, capable of allow a maximum of 21 ml of whole blood or two swabs additional and able to give consent
Key inclusion criteria (5 listed)
- All-comers clinical subjects (ambulatory)
- Hospitalized patients
- Pregnant women (all comers)
- Subjects on dialysis
- Known subjects positive for targeted pathogens
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampleVenuous blood sampling | Other | Cohort of patients presenting infectious diseases |
Primary outcome
Evaluation of clinical and analytical performance of In vitro diagnostic tests used in routine care for infectious diseases by using ROC curve
Time frame: 24 months
* Venipuncture sampling * Blood sampling by capillary action * Swab sampling * Salivary samples * Urine sampling * Dried Blood Spot (DBS) sampling
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara Pernicni, Dr study director
Cerba Xpert
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infectious Disease, run by CerbaXpert at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Barbara Perniconi, Dr (0142657831, bperniconi@cerbaresearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of clinical and analytical performance of In vitro diagnostic tests used in routine care for infectious diseases by using ROC curve (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2023.