Respiferon Project

NCT06017310 | Unknown

• 1 other identifier: 69HCL23_0697
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

Respiratory viral infections (RVIs) represent a major public health problem and a great burden in terms of morbidity and mortality in children and adults worldwide. To ascertain the source of an infection, microbiology laboratories routinely perform a crucial step: the search for the pathogen through Polymerase Chain Reaction (PCR). Due to the extensive variety of pathogens, testing for the existence of all potential viruses, bacteria, or fungi accountable for the infection is an impractical and time-intensive endeavor. Furthermore, the rise of novel pathogens, exemplified by those accountable for the recent SARS-CoV-2 pandemic, underscores the urgency of promptly developing new innovative diagnostic tests. To address these needs, researchers have dedicated several years to developing indirect methodologies notably centered around utilizing markers derived from the host's immune system. Among these, one particularly promising approach focuses on measuring the expression of interferon-stimulated genes, which are uniquely triggered by viral infections, thereby facilitating viral diagnosis. This methodology's efficacy has been proven in the context of SARS-CoV-2 infections. This study's objective is to assess the functionality of such a tool across a spectrum of Respiratory Viral Infections (RVIs) prevalent within a French population during the winter season.

Conditions

Respiratory Viral Infection

Keywords

respiratory viruses; Nasal IFN-1 Score; Nasopharyngeal Swab; Replicative virus; Infectiousness

Outcome Measures

Primary Outcomes (1)

• Presence or Absence of a replicative virus detected by viral culture

  RT-qPCR/qPCR-positive NPS will be inoculated on suitable cell lines using a culture medium appropriate for growth. Plates will be incubated at 33°C in 5% CO2 for 96 hours. Positive samples will be harvested for the confirmation technique, while negative samples will be cultured for 8 days. RNA or DNA from infected cells will be harvested and will be assayed with Panther Fusion® RT-PCR/PCR kits (Hologic Inc., San Diego, CA, USA) for viral identification, except for RSV and influenza A and B viruses (IAV/IBV) which were detected by immunofluorescence using Thermo ScientificTM IMAGENTM kits (Thermo Fischer Scientific, Waltham, MA, USA).

  One sample at inclusion

Study Arms (2)

Replicative viruses

Presence of a replicative virus determined by viral culture

Diagnostic Test: Evaluate the performance of IFN I/III

Unreplicative viruses

Absence of a replicative virus determined by viral culture

Diagnostic Test: Evaluate the performance of IFN I/III

Interventions

Evaluate the performance of IFN I/III DIAGNOSTIC_TEST

Evaluate the response in diagnosing non-respiratory viral infection.

Replicative viruses; Unreplicative viruses

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients hospitalized at the Hospices Civils de Lyon (HCL) with respiratory infection symptoms. Nasopharyngeal samples positive for the detection of a respiratory virus for which the viral culture has been carried out will be selected by the CRB. After informing the patients of the study, the IFN I/III response can be assessed on these same nasopharyngeal samples (no additional sample necessary). The data thus obtained will allow to determine the capacity of the IFN I/III response to detect replicating viruses.

You may qualify if:

• Positive nasopharyngeal samples for the detection of a virus, for which the replicative character has been established by the viral culture technique (500µL minimum required)
• Samples kept at the CRB since 2018
• Information to patients carried out and non-objection collected-

You may not qualify if:

• N/A

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Infective Agents Institute, Croix rousse Hospital

Lyon, Rhone, 69004, France

RECRUITING

Study Design

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

Study Record Dates

• First Submitted: August 24, 2023
• First Posted: August 30, 2023
• Study Start: November 11, 2022
• Primary Completion: March 30, 2024
• Study Completion: December 31, 2024
• Last Updated: August 30, 2023

Record last verified: 2023-08

Locations

FR (1)