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

Recruiting

• Conditions: Influenza Infection

• Registration Number: NCT06998264
• Lead Sponsor: University Hospital, Geneva

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-03-04
• Study First Submitted: 2025-03-28
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-21
• Last Update Submitted: 2025-05-21
• Study First Posted: 2025-05-31
• Last Update Posted: 2025-05-31
• Primary Completion: 2026-11
• Study Completion: 2026-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pro-inflammatory cytokine levels in nasal fluid by a multiplex assay	1 month

Secondary Outcome Measures

Name	Time	Method
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 11: medical consultation for a respiratory disease	1 month
Clinical outcome measure 12: new prescription of antibiotics or corticosteroids	1 month
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 10: rehospitalization	1 month

Trial Locations

Locations (1)

Geneva University Hospitals; 🇨🇭 Geneva, Switzerland