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Respiferon Project

Evaluation of the Type 1 IFN Response in Viral Infections

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06017310
Acronym
Respiferon
Enrollment
1000
Registered
2023-08-30
Start date
2022-11-11
Completion date
2024-12-31
Last updated
2023-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Viral Infection

Keywords

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

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.

Interventions

DIAGNOSTIC_TESTEvaluate the performance of IFN I/III

Evaluate the response in diagnosing non-respiratory viral infection.

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
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-

Exclusion criteria

* N/A

Design outcomes

Primary

MeasureTime frameDescription
Presence or Absence of a replicative virus detected by viral cultureOne sample at inclusionRT-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).

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026