- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06017310
Respiferon Project (Respiferon)
Evaluation of the Type 1 IFN Response in Viral Infections
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
Rhone
-
Lyon, Rhone, France, 69004
- Recruiting
- Infective Agents Institute, Croix rousse Hospital
-
Contact:
- Sophie Trouillet-Assant, PhD
- Phone Number: 04 72 67 87 80
- Email: Sophie.trouillet-assant@chu-lyon.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
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.
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Replicative viruses
Presence of a replicative virus determined by viral culture
|
Evaluate the response in diagnosing non-respiratory viral infection.
|
Unreplicative viruses
Absence of a replicative virus determined by viral culture
|
Evaluate the response in diagnosing non-respiratory viral infection.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Presence or Absence of a replicative virus detected by viral culture
Time Frame: 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).
|
One sample at inclusion
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69HCL23_0697
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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