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

NCT04515446 | Active Not Recruiting

• 1 other identifier: 18-06
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Flu

Outcome Measures

Primary Outcomes (1)

• 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 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

  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

Study Arms (1)

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.

Diagnostic Test: Rapid test for diagnosis orientation; Diagnostic Test: quantitative PCR

Interventions

Rapid test for diagnosis orientation DIAGNOSTIC_TEST

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.

Also known as: TROD

TROD + PCR diagnosis

quantitative PCR DIAGNOSTIC_TEST

Molecular biology method of gene amplification in vitro. It allows a large number of known DNA or RNA sequences to be duplicated

TROD + PCR diagnosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Refusal to participate
• Admission to intensive care
• Palliative care
• Unable to give inform consent
• Patients under legal protection

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead
• Centre Hospitalier Princesse Grace: collaborator

Study Sites (1)

Centre Hospitalier Princesse Grace

Monaco, Municipality of Monaco, 98000, Monaco

Location

Related Publications (3)

• 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.

  PMID: 25061965 RESULT

• 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.

  PMID: 24584247 RESULT

• 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.

  PMID: 26107631 RESULT

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Monocentric, prospective, transversal, diagnostic measurement, blind, descriptive study

Study Record Dates

• First Submitted: January 7, 2020
• First Posted: August 17, 2020
• Study Start: February 4, 2020
• Primary Completion: March 10, 2023
• Study Completion: March 10, 2026
• Last Updated: December 8, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

MO (1)