Infectious Prospective Collection for Biological Analysis

NCT06159270 | Unknown

• 1 other identifier: Infectieux 1
• Study Type: observational
• Target: 22,870
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Infectious Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Cohort of patients presenting infectious diseases

Other: Blood sample

Interventions

Blood sample OTHER

Venuous blood sampling

Cohort of patients presenting infectious diseases

Eligibility Criteria

• Age: 18 Years - 88 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• All-comers clinical subjects (ambulatory)
• Hospitalized patients
• Pregnant women (all comers)
• Subjects on dialysis
• Known subjects positive for targeted pathogens

You may not qualify if:

• 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

Sponsors & Collaborators

• CerbaXpert: lead

Study Sites (1)

Cerba Xpert

Saint-Ouen-l'Aumône, France

RECRUITING

MeSH Terms

Conditions

Communicable Diseases

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Barbara Pernicni, Dr

  Cerba Xpert

  STUDY DIRECTOR

Central Study Contacts

Barbara Perniconi, Dr

CONTACT

0142657831; bperniconi@cerbaresearch.com

Guillaume Franc

CONTACT

0142657831; gfranc@cerbaresearch.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2023
• First Posted: December 6, 2023
• Study Start: May 18, 2019
• Primary Completion: May 18, 2025
• Study Completion: May 18, 2025
• Last Updated: December 6, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)