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 2026
- Phase
- Interventional
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 completion10 Mar 2023
- Study completion10 Mar 2026 (estimated)
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.
- 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
- Oct 2025
- First submitted
- 7 Jan 2020
- Last updated
- 8 Dec 2025
- 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