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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2-5
SponsorUniversity Hospital, Geneva

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 2-5 years

Presenting clinical signs of an influenza-like illness

Having a concomitant positive laboratory test for influenza.

Disqualifiers

Immunosuppression

Intubation or under invasive mechanical ventilation

Co-infection with RSV or SARS-CoV-2

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

40 Participants
are grouped into 1 trial group
Group A: Flu kids

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Geneva

Lead sponsor

University of Geneva, Switzerland

Sponsor institution