Influenza Infection
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
University Hospital, Geneva
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Years to 5 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pro-inflammatory cytokine levels in nasal fluid by a multiplex assay | 1 month |
Secondary
| Measure | Time frame |
|---|---|
| Influenza-specific antibody titers in nasal fluid and blood by ELISA or multiplex assay | 1 month |
| Influenza virus load by specific quantitative RT-PCR assay in nasal cavity and/or saliva | 1 month |
| Levels of blood cytokines by multiplex assay | 1 month |
| Clinical outcome measure 1: nature and severity of symptoms | 1 month |
| Clinical outcome measure 2: number of days with fever | 1 month |
| Clinical outcome measure 3: number of days with oxygen | 1 month |
| Clinical outcome measure 4: highest FiO2 | 1 month |
| Phenotypes and frequencies of immune in nasal cavity and in blood cells by flow cytometry | 1 month |
| Clinical outcome measure 6: transfer to ICU or IMCU | 1 month |
| Clinical outcome measure 7: length of stay in intensive care | 1 month |
| Clinical outcome measure 8: intubation or mechanical ventilation | 1 month |
| Clinical outcome measure 9: mortality | 1 month |
| Clinical outcome measure 10: rehospitalization | 1 month |
| Clinical outcome measure 11: medical consultation for a respiratory disease | 1 month |
| Clinical outcome measure 12: new prescription of antibiotics or corticosteroids | 1 month |
| Clinical outcome measure 5: secondary bacterial infection | 1 month |
Countries
Switzerland
Contacts
Primary ContactJennifer Villers, PhD
Outcome results
None listed