Clinical trial NCT06998264: In-depth Analysis of the Immune Responses in the Upper Respiratory Tract of Influenza-infected Children
Official title: In-depth Analysis of the Immune Responses in the Upper Respiratory Tract of Influenza-infected Children
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Influenza Infection
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2025-05-31
Enrollment: 40
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited among patients hospitalized or visiting the emergencies at the Geneva University Hospitals (HUG).

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.


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

Primary outcomes:
measure: Pro-inflammatory cytokine levels in nasal fluid by a multiplex assay
timeFrame: 1 month
Secondary outcomes:
measure: Phenotypes and frequencies of immune in nasal cavity and in blood cells by flow cytometry
timeFrame: 1 month
measure: Influenza-specific antibody titers in nasal fluid and blood by ELISA or multiplex assay
timeFrame: 1 month
measure: Influenza virus load by specific quantitative RT-PCR assay in nasal cavity and/or saliva
timeFrame: 1 month
measure: Levels of blood cytokines by multiplex assay
timeFrame: 1 month
measure: Clinical outcome measure 1: nature and severity of symptoms
timeFrame: 1 month
measure: Clinical outcome measure 2: number of days with fever
timeFrame: 1 month
measure: Clinical outcome measure 3: number of days with oxygen
timeFrame: 1 month
measure: Clinical outcome measure 4: highest FiO2
timeFrame: 1 month
measure: Clinical outcome measure 5: secondary bacterial infection
timeFrame: 1 month
measure: Clinical outcome measure 6: transfer to ICU or IMCU
timeFrame: 1 month
measure: Clinical outcome measure 7: length of stay in intensive care
timeFrame: 1 month
measure: Clinical outcome measure 8: intubation or mechanical ventilation
timeFrame: 1 month
measure: Clinical outcome measure 9: mortality
timeFrame: 1 month
measure: Clinical outcome measure 10: rehospitalization
timeFrame: 1 month
measure: Clinical outcome measure 11: medical consultation for a respiratory disease
timeFrame: 1 month
measure: Clinical outcome measure 12: new prescription of antibiotics or corticosteroids
timeFrame: 1 month
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Geneva University Hospitals
Study officials:
affiliation: University of Geneva
name: Arnaud Didierlaurent, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Geneva
name: Arnaud L'Huillier, MD
role: PRINCIPAL_INVESTIGATOR
References: