FluVIRIDAENCT04515446
Quantification of Viral Load in the Upper Respiratory Tract in Patients Treated With Olsetamivir for Influenza
A study testing Rapid test for diagnosis orientation and quantitative PCR in people with Flu, run by Centre Hospitalier Universitaire de Nice at 1 site in Monaco.
Trial summary
Seasonal influenza is a frequent disorder with high impact on morbidity and mortality and significant burden on healthcare-related cost. In France, the 2018-2019 flu epidemic has led to 13,100 all-cause death including 9,900 death directly related to the viral infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Flu
- What is being tested?
- Rapid test for diagnosis orientation and quantitative PCR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteMonaco
- Study dates
- 4 Feb 2020to 10 Mar 2023
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (≥18 years)
- Positive testing for influenza (A or B)
- Patients hospitalized and treated with olsetamivir
- Signature of informed consent
- Affiliation to healthcare insurance (France, Monaco)
Who cannot join
- Refusal to participate
- Admission to intensive care
- Palliative care
- Unable to give inform consent
- Patients under legal protection
Trial locations and contacts
1 site in 1 country.
Monaco1 site
Centre Hospitalier Princesse Grace
Monaco, Municipality of Monaco, 98000
About this study
Official title: Sequential Quantification of Viral Load in the Upper Respiratory Tract in Adult Patients Admitted for Influenza and Treated With Olsetamivir
Seasonal influenza is a frequent disorder with high impact on morbidity and mortality and significant burden on healthcare-related cost. In France, the 2018-2019 flu epidemic has led to 13,100 all-cause death including 9,900 death directly related to the viral infection.
As cross-transmission of influenza is responsible for nosocomial outbreaks, preventing transmission of infectious agents in healthcare settings is a major issue. If vaccination of patients and healthcare givers remains cornerstone, control procedures are mandatory. Therefore patients admitted with influenza require isolation precautions including admission in a single room and protective measures. Based on experts advise, isolation is currently recommended for 5 to 8 days. Duration of isolation depends on immune status and antiviral therapy. However, during periods of epidemic, every hospital room is valuable and each ressource has to be tightly used. Risk of contamination is related to the presence of influenza in the upper airways. To the Promoteur 's knowledge, presence of influenza in the upper airways has not been studied in patients receiving oseltamivir. The question is : Do duration of isolation in patients admitted with flu decreas when they are treated with antiviral therapy. To answer this question The Promoteur would aim to determine influenza carriage in the upper airways in in-patients treated by olsetamivir.
- Conditions
- Flu
- Being tested
- Rapid test for diagnosis orientation, quantitative PCR
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid test for diagnosis orientationDiagnostic test
Also called TROD
Rapid tests screen for influenza viruses in less than 30 minutes. They detect internal viral nucleoproteins by immunochromatography using specific antibodies attached to one or more strips.
quantitative PCRDiagnostic test
Molecular biology method of gene amplification in vitro. It allows a large number of known DNA or RNA sequences to be duplicated
| Study group | Role | What they receive |
|---|---|---|
| TROD + PCR diagnosis | Other | For each patient positive for flu with a rapid diagnostic test, sequential nasopharyngeal (NP) samples will be collected for quantitative PCR every day from D1 to D8 or until discharge (if before D8). Sequential quantitative PCR will quantify influenza virus load in the upper airways. Receives: Diagnostic Test: Rapid test for diagnosis orientation; Diagnostic Test: quantitative PCR |
What is being measured
The primary outcome is the main question the study is designed to answer.
The duration of influenza virus carriage in the upper airways in patients treated with olsetamivir will be observed
Measured: Within 8 days following patient's participation
Secondary outcomes (3)
Duration of influenza virus carriage in the upper airways among patients treated with olsetamivir according to the viral strand (A or B) will be mesured
Measured: Within 8 days following patient's participation
Duration of influenza virus carriage in the upper airways among patients treated with olsetamivir according to their vaccination status and comorbidities will be mesured and compared
Measured: Within 8 days following patient's participation
Difference in the number of days in isolation in patients hospitalized and treated with olsetamivir will be evaluated
Measured: 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2020
- Study start4 Feb 2020
- Primary completion9 Mar 2023
- Study completion10 Mar 2023
Why it stopped: The study concerned Influenza. However, since it was launched at the time of COVID, influenza patients and studies were no more a priority. Therefore, inclusions were difficult.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for FluStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Monocentric, prospective, transversal, diagnostic measurement, blind, descriptive study
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Princesse Grace
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04515446
- Sponsor's protocol ID
- 18-06
- Acronym
- VIRIDAE
- Status last verified
- Nov 2026
- First submitted
- 7 Jan 2020
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no data sharing is planned
Publications
Li X, Zhang Z, Yu A, Ho SY, Carr MJ, Zheng W, Zhang Y, Zhu C, Lei F, Shi W. Global and local persistence of influenza A(H5N1) virus. Emerg Infect Dis. 2014 Aug;20(8):1287-95. doi: 10.3201/eid2008.130910.
PubMed 25061965Keeler SP, Dalton MS, Cressler AM, Berghaus RD, Stallknecht DE. Abiotic factors affecting the persistence of avian influenza virus in surface waters of waterfowl habitats. Appl Environ Microbiol. 2014 May;80(9):2910-7. doi: 10.1128/AEM.03790-13. Epub 2014 Feb 28.
PubMed 24584247Patterson Ross Z, Komadina N, Deng YM, Spirason N, Kelly HA, Sullivan SG, Barr IG, Holmes EC. Inter-Seasonal Influenza is Characterized by Extended Virus Transmission and Persistence. PLoS Pathog. 2015 Jun 24;11(6):e1004991. doi: 10.1371/journal.ppat.1004991. eCollection 2015 Jun.
PubMed 26107631
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sequential Quantification of Viral Load in the Upper Respiratory Tract in Adult Patients Admitted for Influenza and Treated With Olsetamivir
- ClinicalTrials.gov ID
- NCT04515446
- Acronym / sponsor ID
- VIRIDAE / 18-06
- Conditions
- Flu
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study concerned Influenza. However, since it was launched at the time of COVID, influenza patients and studies were no more a priority. Therefore, inclusions were difficult.
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Collaborators
- Centre Hospitalier Princesse Grace
- Study start
- 4 Feb 2020 (actual)
- Primary completion
- 9 Mar 2023 (actual)
- Study completion
- 10 Mar 2023 (actual)
- First posted
- 17 Aug 2020 (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.
Seasonal influenza is a frequent disorder with high impact on morbidity and mortality and significant burden on healthcare-related cost. In France, the 2018-2019 flu epidemic has led to 13,100 all-cause death including 9,900 death directly related to the viral infection.
As cross-transmission of influenza is responsible for nosocomial outbreaks, preventing transmission of infectious agents in healthcare settings is a major issue. If vaccination of patients and healthcare givers remains cornerstone, control procedures are mandatory. Therefore patients admitted with influenza require isolation precautions including admission in a single room and protective measures. Based on experts advise, isolation is currently recommended for 5 to 8 days. Duration of isolation depends on immune status and antiviral therapy. However, during periods of epidemic, every hospital room is valuable and each ressource has to be tightly used. Risk of contamination is related to the presence of influenza in the upper airways. To the Promoteur 's knowledge, presence of influenza in the upper airways has not been studied in patients receiving oseltamivir. The question is : Do duration of isolation in patients admitted with flu decreas when they are treated with antiviral therapy. To answer this question The Promoteur would aim to determine influenza carriage in the upper airways in in-patients treated by olsetamivir.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Monocentric, prospective, transversal, diagnostic measurement, blind, descriptive study
| Arm | Type | Receives |
|---|---|---|
| TROD + PCR diagnosis | Other | Diagnostic Test: Rapid test for diagnosis orientation, Diagnostic Test: quantitative PCRFor each patient positive for flu with a rapid diagnostic test, sequential nasopharyngeal (NP) samples will be collected for quantitative PCR every day from D1 to D8 or until discharge (if before D8). Sequential quantitative PCR will quantify influenza virus load in the upper airways. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients (≥18 years)
- Positive testing for influenza (A or B)
- Patients hospitalized and treated with olsetamivir
- Signature of informed consent
- Affiliation to healthcare insurance (France, Monaco)
Key exclusion criteria (5 listed)
- Refusal to participate
- Admission to intensive care
- Palliative care
- Unable to give inform consent
- Patients under legal protection
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 |
|---|---|---|
| Rapid test for diagnosis orientationAlso: TRODRapid tests screen for influenza viruses in less than 30 minutes. They detect internal viral nucleoproteins by immunochromatography using specific antibodies attached to one or more strips. | Diagnostic test | TROD + PCR diagnosis |
| quantitative PCRMolecular biology method of gene amplification in vitro. It allows a large number of known DNA or RNA sequences to be duplicated | Diagnostic test | TROD + PCR diagnosis |
Primary outcome
The duration of influenza virus carriage in the upper airways in patients treated with olsetamivir will be observed
Time frame: Within 8 days following patient's participation
3 secondary outcomes
Duration of influenza virus carriage in the upper airways among patients treated with olsetamivir according to the viral strand (A or B) will be mesured
Time frame: Within 8 days following patient's participation
Duration of influenza virus carriage in the upper airways among patients treated with olsetamivir according to their vaccination status and comorbidities will be mesured and compared
Time frame: Within 8 days following patient's participation
Difference in the number of days in isolation in patients hospitalized and treated with olsetamivir will be evaluated
Time frame: 21 months
Results and safety
The study was stopped early (reason given: The study concerned Influenza. However, since it was launched at the time of COVID, influenza patients and studies were no more a priority. Therefore, inclusions were difficult.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Results publication: PubMed 25061965Li X, Zhang Z, Yu A, Ho SY, Carr MJ, Zheng W, Zhang Y, Zhu C, Lei F, Shi W. Global and local persistence of influenza A(H5N1) virus. Emerg Infect Dis. 2014 Aug;20(8):1287-95. doi: 10.3201/eid2008.130910.
- Results publication: PubMed 24584247Keeler SP, Dalton MS, Cressler AM, Berghaus RD, Stallknecht DE. Abiotic factors affecting the persistence of avian influenza virus in surface waters of waterfowl habitats. Appl Environ Microbiol. 2014 May;80(9):2910-7. doi: 10.1128/AEM.03790-13. Epub 2014 Feb 28.
- Results publication: PubMed 26107631Patterson Ross Z, Komadina N, Deng YM, Spirason N, Kelly HA, Sullivan SG, Barr IG, Holmes EC. Inter-Seasonal Influenza is Characterized by Extended Virus Transmission and Persistence. PLoS Pathog. 2015 Jun 24;11(6):e1004991. doi: 10.1371/journal.ppat.1004991. eCollection 2015 Jun.
- Individual participant dataSharing planned: No. no data sharing is planned
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rapid test for diagnosis orientation and quantitative PCR in people with Flu, run by Centre Hospitalier Universitaire de Nice at 1 site in Monaco.
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 5 inclusion and 5 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: stopped early, as of the sponsor's last update on 4 Nov 2026. 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 Monaco. 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?
The study was stopped early (reason given: The study concerned Influenza. However, since it was launched at the time of COVID, influenza patients and studies were no more a priority. Therefore, inclusions were difficult.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The duration of influenza virus carriage in the upper airways in patients treated with olsetamivir will be observed (time frame: Within 8 days following patient's participation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04515446, which also lists 3 linked publications.
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 4 Nov 2026.