In-depth Analysis of the Immune Responses in the Upper Respiratory Tract of Influenza-infected Children (NoseFlu-Kids)

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.

Study Overview

• Status: Recruiting
• Conditions: Influenza Infection

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Jennifer Villers, PhD; Phone Number: +41 79 553 88 86; Email: jennifer.villers@hug.ch

Study Locations

• Switzerland
  • Geneva, Switzerland, 1205
    • Recruiting
    • Geneva University Hospitals
    • Contact: Jennifer Villers, PhD; Phone Number: +41795538886; Email: jennifer.villers@hug.ch
    • Principal Investigator: Arnaud L'Huillier, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited among patients hospitalized or visiting the emergencies at the Geneva University Hospitals (HUG).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Flu kids; Patients aged 2-5 years old hospitalized with flu-like symptoms and a laboratory-confirmed influenza infection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pro-inflammatory cytokine levels in nasal fluid by a multiplex assay	1 month

Secondary Outcome Measures

Outcome Measure	Time Frame
Phenotypes and frequencies of immune in nasal cavity and in blood cells by flow cytometry	1 month
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
Clinical outcome measure 5: secondary bacterial infection	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

Collaborators and Investigators

• Sponsor: University Hospital, Geneva
• Investigators: Principal Investigator: Arnaud Didierlaurent, PhD, University of Geneva; Principal Investigator: Arnaud L'Huillier, MD, University Hospital, Geneva

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: March 28, 2025
• First Submitted That Met QC Criteria: May 21, 2025
• First Posted (Actual): May 31, 2025

Study Record Updates

• Last Update Posted (Actual): May 31, 2025
• Last Update Submitted That Met QC Criteria: May 21, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Influenza, Human
• Other Study ID Numbers: 2024-01409

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No