Respiferon Project

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Recruiting

CT.gov ID

NCT06017310

Collaborator

(none)

1,000

Enrollment

Location

25.7

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Viral Infection	Diagnostic Test: Evaluate the performance of IFN I/III

Study Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Evaluation of the Type 1 IFN Response in Viral Infections

Actual Study Start Date :

Nov 11, 2022

Anticipated Primary Completion Date :

Mar 30, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Replicative viruses Presence of a replicative virus determined by viral culture	Diagnostic Test: Evaluate the performance of IFN I/III Evaluate the response in diagnosing non-respiratory viral infection.
Unreplicative viruses Absence of a replicative virus determined by viral culture	Diagnostic Test: Evaluate the performance of IFN I/III Evaluate the response in diagnosing non-respiratory viral infection.

Arm

Intervention/Treatment

Replicative viruses

Presence of a replicative virus determined by viral culture

Diagnostic Test: Evaluate the performance of IFN I/III

Evaluate the response in diagnosing non-respiratory viral infection.

Unreplicative viruses

Absence of a replicative virus determined by viral culture

Diagnostic Test: Evaluate the performance of IFN I/III

Evaluate the response in diagnosing non-respiratory viral infection.

Outcome Measures

Primary Outcome Measures

Presence or Absence of a replicative virus detected by viral culture [One sample at inclusion]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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-