Quantification of Viral Load in the Upper Respiratory Tract in Patients Treated With Olsetamivir for Influenza

Study Overview
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Brief Summary
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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.

Official Title
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Sequential Quantification of Viral Load in the Upper Respiratory Tract in Adult Patients Admitted for Influenza and Treated With Olsetamivir

Conditions
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Flu

Intervention / Treatment
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* Diagnostic Test: Rapid test for diagnosis orientation
* Diagnostic Test: quantitative PCR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: Refusal to participate Admission to intensive care Palliative care Unable to give inform consent Patients under legal protection

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Monocentric, prospective, transversal, diagnostic measurement, blind, descriptive study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: TROD + PCR diagnosis<br>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. | Diagnostic Test: Rapid test for diagnosis orientation<br>* 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.<br>* Other names: TROD;Diagnostic Test: quantitative PCR<br>* Molecular biology method of gene amplification in vitro. It allows a large number of known DNA or RNA sequences to be duplicated<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The duration of influenza virus carriage in the upper airways in patients treated with olsetamivir will be observed |  | Within 8 days following patient's participation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 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 |  | 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 |  | 21 months |