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Biomarkers for the Prognosis of Influenza in Children

NCT03231995 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 145

Last updated 2022-06-08

No results posted yet for this study

Summary

Context: Seasonal influenza affects 2.5 to 3 million people each year in France, resulting in 1500 to 2000 severe cases seen in intensive care units. The severity of influenza is related to, among other things, its respiratory or neurological complications, observed especially in children. Early determination of the severity of influenza is a critical step to avoid in appropriate treatment and care for patients and to improve their survival. Viral, human but also environmental factors have been described as having an important role in determining this severity. Several studies suggest that the nasopharyngeal microbiome may be involved in the incidence and severity of respiratory viral infections. During influenza infection, the respiratory microbiota is significantly altered. In animal models, particularly murine models, the microbiota regulates the immune response to influenza virus infection. In a retrospective preliminary study, the investigators showed that the composition of the nasopharyngeal bacterial microbiota is different between children who develop a severe or moderate influenza. This difference was observed on respiratory specimens at admission to pediatric emergencies within two days of onset of symptoms.

Hypotheses :

* The respiratory microbiome is a determining factor in the clinical course of influenza infection (benign vs. severe with respiratory or neurological complication)
* The respiratory microbiome can be used as a prognostic biomarker of the clinical course of influenza Originality: There are currently no clinical and / or virological markers to predict the clinical course of influenza infection. This study will define biomarkers of the respiratory microbiome to discriminate patients who will develop a severe influenza from those who will develop a moderate influenza. These prognostic biomarkers could be used to rapidly refer patients at risk to intensive care units, thus improving patient management and care. Moreover, at the fundamental level, this study will specify the role of the microbiome in the severity of influenza infection.

Conditions

Interventions

BIOLOGICAL

Collection of nasopharyngeal specimen collected at D0, D1, D2 and D5.

Analyses will be performed on nasopharyngeal specimen collected at D0, D1, D2 and D5. Definition and validation of nasopharyngeal microbiome biomarkers (bacterial, viral, transcriptomic signature)

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-15
Primary Completion
2022-04-20
Completion
2022-04-20

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03231995 on ClinicalTrials.gov