About this trial
The NoseFlu-Kids project aims at characterizing the immune response in the upper respiratory tract in children aged 2 to 5 with a laboratory-confirmed influenza infection. The immune response during the acute phase of the infection and after recovery will be compared to that of control children with no infection or vaccinated with the inactivated flu vaccine by the nasal route (recruited as part of a mirror study in Oxford).
The primary objective of this observational study is to quantify the inflammatory response in the nasal cavity and to correlate it with viral load and with clinical parameters. The study also aims to compare the inflammatory response measured in the nose to that measured in the blood.
Participants will have two study visits including a blood draw, several nasal samplings (nasal lining fluid and nasal cells) and a saliva sampling, one within 72 hours of their hospital admission and another one month later. Nasal lining fluid and saliva will be obtained every two or three days until symptoms disappear. During those visits, questions regarding symptoms will be asked.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 2-5 years
Presenting clinical signs of an influenza-like illness
Having a concomitant positive laboratory test for influenza.
Disqualifiers
Immunosuppression
Intubation or under invasive mechanical ventilation
Co-infection with RSV or SARS-CoV-2
Trial population
Participants will be recruited among patients hospitalized or visiting the emergencies at the Geneva University Hospitals (HUG).
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Pro-inflammatory cytokine levels in nasal fluid by a multiplex assay
Secondary outcomes
Phenotypes and frequencies of immune in nasal cavity and in blood cells by flow cytometry
Influenza-specific antibody titers in nasal fluid and blood by ELISA or multiplex assay
Influenza virus load by specific quantitative RT-PCR assay in nasal cavity and/or saliva
Levels of blood cytokines by multiplex assay
Sponsors and contacts
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University Hospital, Geneva
Lead sponsor
University of Geneva, Switzerland
Sponsor institution