Quantification of Viral Load in the Upper Respiratory Tract in Patients Treated With Olsetamivir for Influenza
- Conditions
- Flu
- Interventions
- Diagnostic Test: Rapid test for diagnosis orientationDiagnostic Test: quantitative PCR
- Registration Number
- NCT04515446
- Lead Sponsor
- Centre Hospitalier Universitaire de Nice
- Brief 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.
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
- 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)
- Refusal to participate
- Admission to intensive care
- Palliative care
- Unable to give inform consent
- Patients under legal protection
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description TROD + PCR diagnosis Rapid test for diagnosis orientation 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. TROD + PCR diagnosis quantitative PCR 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (1)
Centre Hospitalier Princesse Grace
🇲🇨Monaco, Monaco