Clinical trial NCT04515446: Quantification of Viral Load in the Upper Respiratory Tract in Patients Treated With Olsetamivir for Influenza
Official title: Sequential Quantification of Viral Load in the Upper Respiratory Tract in Adult Patients Admitted for Influenza and Treated With Olsetamivir
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Flu
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Princesse Grace
First posted: 2020-08-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Monocentric, prospective, transversal, diagnostic measurement, blind, descriptive study
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: The duration of influenza virus carriage in the upper airways in patients treated with olsetamivir will be observed
timeFrame: Within 8 days following patient's participation
Secondary outcomes:
measure: 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
timeFrame: Within 8 days following patient's participation
measure: 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
timeFrame: Within 8 days following patient's participation
measure: Difference in the number of days in isolation in patients hospitalized and treated with olsetamivir will be evaluated
timeFrame: 21 months
Other outcomes:
Locations:
city: Monaco
country: Monaco
facility: Centre Hospitalier Princesse Grace
Study officials:
References:
citation: 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.
citation: Keeler 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.
citation: Patterson 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.