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NCT Number: NCT06998264

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

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.

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Key information

Conditions

Age range

2 year–5 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Geneva University Hospitals

Geneva, 1205, Switzerland

Location status: Recruiting

Location contact

Arnaud L'Huillier, MD

PRINCIPAL_INVESTIGATOR

Jennifer Villers, PhD

CONTACT

[email protected]

+41795538886

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Study contacts

Contact information is provided by the study sponsor or research team.

Jennifer Villers, PhD

CONTACT

[email protected]

+41 79 553 88 86

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Registry information

Acronym: NoseFlu-Kids

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 31, 2025
Registry last updated
May 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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