Respiratory Viral InfectionRespiferonNCT06017310
Respiferon Project
An observational study of Respiratory Viral Infection, run by Hospices Civils de Lyon at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Respiratory Viral Infection
- What is being tested?
- Evaluate the performance of IFN I/III
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 11 Nov 2022to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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-
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Infective Agents Institute, Croix rousse Hospital
Lyon, Rhone, 69004
Sophie Trouillet-Assant, PhD, 04 72 67 87 80, Sophie.trouillet-assant@chu-lyon.fr
About this study
Official title: 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.
- Conditions
- Respiratory Viral Infection
- Being tested
- Evaluate the performance of IFN I/III
- Keywords
- respiratory viruses, Nasal IFN-1 Score, Nasopharyngeal Swab, Replicative virus, Infectiousness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluate the performance of IFN I/IIIDiagnostic test
Evaluate the response in diagnosing non-respiratory viral infection.
| Study group | Role | What they receive |
|---|---|---|
| Replicative viruses | Presence of a replicative virus determined by viral culture Receives: Diagnostic Test: Evaluate the performance of IFN I/III | |
| Unreplicative viruses | Absence of a replicative virus determined by viral culture Receives: Diagnostic Test: Evaluate the performance of IFN I/III |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: One sample at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start11 Nov 2022
- Primary completion30 Mar 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Viral InfectionStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06017310
- Sponsor's protocol ID
- 69HCL23_0697
- Acronym
- Respiferon
- Status last verified
- Aug 2023
- First submitted
- 24 Aug 2023
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Type 1 IFN Response in Viral Infections
- ClinicalTrials.gov ID
- NCT06017310
- Acronym / sponsor ID
- Respiferon / 69HCL23_0697
- Conditions
- Respiratory Viral Infection
- Keywords
- respiratory viruses, Nasal IFN-1 Score, Nasopharyngeal Swab, Replicative virus, Infectiousness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 11 Nov 2022 (actual)
- Primary completion
- 30 Mar 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 30 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Replicative viruses | – | Diagnostic Test: Evaluate the performance of IFN I/IIIPresence of a replicative virus determined by viral culture |
| Unreplicative viruses | – | Diagnostic Test: Evaluate the performance of IFN I/IIIAbsence of a replicative virus determined by viral culture |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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-
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluate the performance of IFN I/IIIEvaluate the response in diagnosing non-respiratory viral infection. | Diagnostic test | Replicative viruses, Unreplicative viruses |
Primary outcome
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Infective Agents Institute, Croix rousse Hospital
Lyon, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Viral Infection, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence or Absence of a replicative virus detected by viral culture (time frame: One sample at inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2023.