ClinicalTrials.gg
RecruitingNCT06998264NoseFlu-KidsUpdated May 31, 2025

In-depth Analysis of the Immune Responses in the Upper Respiratory Tract of Influenza-infected Children

An observational study in Influenza Infection, sponsored by University Hospital, Geneva. Recruiting at 1 site in Switzerland. Open to participants aged 2 Years to 5 Years. Per ClinicalTrials.gov, last updated 2025-05-31.

Sponsored by University Hospital, Geneva · Observational

From the registry’s dates

  • Started Mar 2025; still recruiting 1 year 7 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
40
Ages
2 Years to 5 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Influenza Infection
03

In context

Lead sponsor

University Hospital, Geneva is the lead sponsor of 378 studies on the registry; 69 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 5 Years
Sexes eligible
All
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).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Aged 2-5 years
  • Presenting clinical signs of an influenza-like illness
  • Having a concomitant positive laboratory test for influenza.

Exclusion criteria

Exclusion criteria:

  • Immunosuppression
  • Intubation or under invasive mechanical ventilation
  • Co-infection with RSV or SARS-CoV-2
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
40 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Flu kids

    Patients aged 2-5 years old hospitalized with flu-like symptoms and a laboratory-confirmed influenza infection

06

What researchers measure

Primary outcomes

  1. Pro-inflammatory cytokine levels in nasal fluid by a multiplex assay

    Time frame: 1 month

Secondary outcomes

  1. Phenotypes and frequencies of immune in nasal cavity and in blood cells by flow cytometry

    Time frame: 1 month

  2. Influenza-specific antibody titers in nasal fluid and blood by ELISA or multiplex assay

    Time frame: 1 month

  3. Influenza virus load by specific quantitative RT-PCR assay in nasal cavity and/or saliva

    Time frame: 1 month

  4. Levels of blood cytokines by multiplex assay

    Time frame: 1 month

  5. Clinical outcome measure 1: nature and severity of symptoms

    Time frame: 1 month

  6. Clinical outcome measure 2: number of days with fever

    Time frame: 1 month

  7. Clinical outcome measure 3: number of days with oxygen

    Time frame: 1 month

  8. Clinical outcome measure 4: highest FiO2

    Time frame: 1 month

  9. Clinical outcome measure 5: secondary bacterial infection

    Time frame: 1 month

  10. Clinical outcome measure 6: transfer to ICU or IMCU

    Time frame: 1 month

  11. Clinical outcome measure 7: length of stay in intensive care

    Time frame: 1 month

  12. Clinical outcome measure 8: intubation or mechanical ventilation

    Time frame: 1 month

  13. Clinical outcome measure 9: mortality

    Time frame: 1 month

  14. Clinical outcome measure 10: rehospitalization

    Time frame: 1 month

  15. Clinical outcome measure 11: medical consultation for a respiratory disease

    Time frame: 1 month

  16. Clinical outcome measure 12: new prescription of antibiotics or corticosteroids

    Time frame: 1 month

07

Study locations

1 of 1 sites recruiting
  • Geneva University Hospitals
    Geneva, 1205, Switzerland
    • Jennifer Villers, PhD · Contact · jennifer.villers@hug.ch · +41795538886
    • Arnaud L'Huillier, MD · Principal investigator
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Mar 2025 (actual). Primary completion is estimated for Nov 2026, 20 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 28, 2025
First posted
May 31, 2025
StartActual
Mar 4, 2025
Primary completionEst.
Nov 2026
CompletionEst.
Nov 2026
Last update
May 31, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 31, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06998264
Responsible party
Prof. Arnaud Didierlaurent (Professor, University of Geneva, Switzerland) — Principal investigator
First posted
May 31, 2025
Start date
Mar 4, 2025
Primary completion
Nov 2026 (estimated)
Completion
Nov 2026 (estimated)
Last update
May 31, 2025

Study contacts

Jennifer Villers, PhD
Contact
jennifer.villers@hug.ch
+41 79 553 88 86
Arnaud Didierlaurent, PhD
principal investigator · University of Geneva, Switzerland
Arnaud L'Huillier, MD
principal investigator · University Hospital, Geneva

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion