NCT06998264|Recruiting
In-depth Analysis of the Immune Responses in the Upper Respiratory Tract of Influenza-infected Children
NoseFlu-Kids
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NoseFlu-Kids
Sponsor study identifier
observational
40
1 country
1
Study Start
March 4, 2025
Actual (reported)Primary Completion
November 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 4, 2025
Actual (reported)March 28, 2025
Actual (reported)May 31, 2025
Actual (reported)November 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
November 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Pro-inflammatory cytokine levels in nasal fluid by a multiplex assay
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
Patients aged 2-5 years old hospitalized with flu-like symptoms and a laboratory-confirmed influenza infection
Participants will be recruited among patients hospitalized or visiting the emergencies at the Geneva University Hospitals (HUG).
Geneva University Hospitals
Geneva, 1205, Switzerland
Blood, nasal cells, nasal lining fluid, saliva
Arnaud Didierlaurent, PhD
University of Geneva, Switzerland
Arnaud L'Huillier, MD
University Hospital, Geneva
First Submitted
March 28, 2025
First Posted
May 31, 2025
Study Start
March 4, 2025
Actual (reported)Primary Completion
November 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Catechin Containing Mask for the Prevention of Influenza Infection
Contact the study team to confirm eligibility.
Study Completion
November 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
May 31, 2025
Record last verified: 2025-05
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Source: ClinicalTrials.gov.
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