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

NCT ID: NCT06998264

Last Updated: 2025-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-04

Study Completion Date

2026-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Influenza Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Flu kids

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Geneva

OTHER

Sponsor Role lead

Responsible Party

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Prof. Arnaud Didierlaurent

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Arnaud Didierlaurent, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Geneva

Arnaud L'Huillier, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Geneva

Locations

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Geneva University Hospitals

Geneva, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Jennifer Villers, PhD

Role: CONTACT

+41 79 553 88 86

Facility Contacts

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Jennifer Villers, PhD

Role: primary

+41795538886

Other Identifiers

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2024-01409

Identifier Type: -

Identifier Source: org_study_id

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