In-depth Analysis of the Immune Responses in the Upper Respiratory Tract of Influenza-infected Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Influenza Infection. Basic parameters: 2 years — 5 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Pro-inflammatory cytokine levels in nasal fluid by a multiplex assay [Time frame: 1 month]
Secondary outcome measures (12)
- Phenotypes and frequencies of immune in nasal cavity and in blood cells by flow cytometry [Time frame: 1 month]
- Influenza-specific antibody titers in nasal fluid and blood by ELISA or multiplex assay [Time frame: 1 month]
- Influenza virus load by specific quantitative RT-PCR assay in nasal cavity and/or saliva [Time frame: 1 month]
- Levels of blood cytokines by multiplex assay [Time frame: 1 month]
- Clinical outcome measure 1: nature and severity of symptoms [Time frame: 1 month]
- Clinical outcome measure 2: number of days with fever [Time frame: 1 month]
- Clinical outcome measure 3: number of days with oxygen [Time frame: 1 month]
- Clinical outcome measure 4: highest FiO2 [Time frame: 1 month]
- Clinical outcome measure 5: secondary bacterial infection [Time frame: 1 month]
- Clinical outcome measure 6: transfer to ICU or IMCU [Time frame: 1 month]
- Clinical outcome measure 7: length of stay in intensive care [Time frame: 1 month]
- Clinical outcome measure 8: intubation or mechanical ventilation [Time frame: 1 month]
Eligibility criteria
Inclusion criteria
- Aged 2-5 years
- Presenting clinical signs of an influenza-like illness
- Having a concomitant positive laboratory test for influenza.
Exclusion criteria
- Immunosuppression
- Intubation or under invasive mechanical ventilation
- Co-infection with RSV or SARS-CoV-2
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Switzerland · 1 center
- Geneva University Hospitals — Geneva
Identifiers
NCT: NCT06998264 · 2024-01409