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

Flu Clinical Trial

— VIRIDAE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04515446
• Other study ID #: 18-06
• Status: Recruiting
• Phase: N/A
• Start date: February 4, 2020
• Est. completion date: October 1, 2021

Study information

• Verified date: December 2019
• Source: Centre Hospitalier Universitaire de Nice
• Contact: Olivia KEITA-PERSE, MD
• Phone: +33 4 92416795
• Email: olivia.keita-perse[@]chpg.mc
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 1, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Flu

Intervention

Diagnostic Test:
• Rapid test for diagnosis orientation
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 PCR
Molecular biology method of gene amplification in vitro. It allows a large number of known DNA or RNA sequences to be duplicated

Locations

Country	Name	City	State
Monaco	Centre Hospitalier Princesse Grace	Monaco

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice	Centre Hospitalier Princesse Grace

Country where clinical trial is conducted

Monaco, 

References & Publications (3)

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 — View 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. — View 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.1004 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Difference in the number of days in isolation in patients hospitalized and treated with olsetamivir will be evaluated		21 months