Biomarkers for the Prognosis of Influenza in Children

NCT03231995 | Completed

• 2 other identifiers: 69HCL17_01752017-A03035-48
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 2

Brief 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

Influenza

Keywords

Severe influenza; biomarkers; respiratory microbiome; prognosis

Outcome Measures

Primary Outcomes (1)

• Definition and evaluation of a microbial signature discriminating patients developing severe influenza from those developing moderate influenza

  On nasopharyngeal specimen collected at inclusion, a microbial signature will be defined as a limited number of bacterial genomic groups (OTU Operational Taxonomic Unit), that will help discriminate the 2 groups of patients (evolution toward a severe or a moderate influenza, evaluated at hospital discharge).

  Day 30

Secondary Outcomes (3)

• sequencing the hypervariable regions of the 16S RNA on the longitudinal respiratory specimens

  Day 1

• sequencing the hypervariable regions of the 16S RNA on the longitudinal respiratory specimens

  Day 2

• sequencing the hypervariable regions of the 16S RNA on the longitudinal respiratory specimens

  Day 5

Study Arms (1)

Respiratory microbiome biomarkers

EXPERIMENTAL

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

Interventions

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

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)

Respiratory microbiome biomarkers

Eligibility Criteria

• Age: Up to 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age \< 5 years
• Seen in an emergency department with influenza confirmed by a positive test (polumerase chain reaction, rapide antigen detection test).

You may not qualify if:

• Presence of associated significant comorbidity (chronic respiratory, cardiac, neurological or metabolic pathology, prematurity, known immunodeficiency)
• Documented non-respiratory bacterial infection
• No consent
• Patient not affiliated to a national health cover

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (2)

CIC groupement Hospitalier Est - Hospices Civils de Lyon

Lyon, 69317, France

Location

Hopital Nord

Saint-Etienne, France

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2017
• First Posted: July 27, 2017
• Study Start: January 15, 2019
• Primary Completion: April 20, 2022
• Study Completion: April 20, 2022
• Last Updated: June 8, 2022

Record last verified: 2022-06

Locations

FR (2)