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

Centre Hospitalier Universitaire de Nice

Status: Active, not recruiting

Conditions: Flu

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04515446

18-06

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

TROD + PCR diagnosis

Other group

Description:

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.

Treatment:

Diagnostic Test: quantitative PCR

Diagnostic Test: Rapid test for diagnosis orientation