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

NCT06998264 | Recruiting

• 1 other identifier: 2024-01409
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Influenza Infection

Outcome Measures

Primary Outcomes (1)

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

  1 month

Secondary Outcomes (16)

• 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

Study Arms (1)

Flu kids

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

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

Geneva University Hospitals

Geneva, 1205, Switzerland

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood, nasal cells, nasal lining fluid, saliva

Study Officials

• Arnaud Didierlaurent, PhD

  University of Geneva

  PRINCIPAL INVESTIGATOR

• Arnaud L'Huillier, MD

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Villers, PhD

CONTACT

+41 79 553 88 86; jennifer.villers@hug.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 28, 2025
• First Posted: May 31, 2025
• Study Start: March 4, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: May 31, 2025

Record last verified: 2025-05

Locations

CH (1)