Characterization of Respiratory Microbiota in Susceptibility to Viral Respiratory Infections

NCT03600753 | Unknown

• 1 other identifier: 2017-23
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The role of the nasopharyngeal mucosal microbiota has recently been emphasized in respiratory diseases. The hypothesis that respiratory infections are linked to an imbalance of the nasopharyngeal microbiota has recently emerged and some studies show a link between the respiratory microbiota, the susceptibility to viral respiratory infections and the severity induced. In a preliminary work on the respiratory microbiota from 225 patients and 48 controls, the investigators found a decrease in the richness and biodiversity of the nasopharyngeal microbiota in patients with a respiratory viral infection as well as an enrichment of their respiratory flora in pathogenic bacteria. Interestingly, these recent years, the development of qPCR for virus diagnosis showed a substantial proportion of asymptomatic carriers of viruses suggesting that the nasopharyngeal microbiota may play a critical role in the genesis and clinical expression of viral respiratory infection, challenging Koch's postulate. The principal objectives of this study are to compare the respiratory microbiota between symptomatic patients with respiratory viral infection and asymptomatic carrier of virus. The aim is to determine the existence of respiratory microbiota profiles associated with the occurrence of viral respiratory infections influencing the clinical expression of virus and to determine the role of the respiratory microbiota in the occurrence of bacterial superinfection which will justify an early antibiotic treatment. The investigators will include 35 symptomatic patients with viral respiratory infection harboring positive qPCR for respiratory virus (influenza A or B, RSV, rhinovirus, metapneumovirus), 35 asymptomatic patients with positive qPCR for respiratory virus and 30 healthy subjects (controls). A pharyngeal and a nasal swabs will be performed for each patient. All the samples will be analyse by culturomics and metagenomic. Culturomic is a high-throughput culture strategy based on the multiplication of culture conditions coupled with the rapid identification of bacteria by MALDI-TOF (Matrix-Assisted Laser Desorption / Ionization-Time-Of-Flight) mass spectrometry.Metagenomics is an high throughput sequencing and will be performed using Miseq ( Illumina technology) targeting the V3-V4 hypervariable regions of the 16S RNA gene.

Conditions

Viral Respiratory Infection

Outcome Measures

Primary Outcomes (3)

• standard microbiological diagnosis of virology

  qPCR influenza A, influenza B, rhinovirus, metapneumovirus and respiratory syncythial virus will be performed according to the laboratory protocol by PCR or immunochromatographic test.

  30 months

• Bacterial metagenomics

  The composition of the respiratory microbiota will be established by high-throughput sequencing of the V3-V4 hypervariable regions of the 16S rRNA gene by Miseq (Illumina)

  30 months

• culturomic

  Culturomic is a high-throughput culture strategy based on the multiplication of culture conditions coupled with the rapid identification of bacteria by MALDI-TOF (Matrix-Assisted Laser Desorption / Ionization-Time-Of-Flight) mass spectrometry ( 14). In the event of an insufficient identification score by MALDI-TOF, the strains are identified by molecular techniques, in particular by sequencing of the 16S rRNA.

  30 months

Secondary Outcomes (3)

• bacteria present in the respiratory flora in healthy group

  30 months

• bacteria present in the respiratory flora of patients

  30 months

• Prognostic factors of viral respiratory infections

  30 months

Study Arms (3)

symptomatic patients

EXPERIMENTAL

symptomatic patients with viral respiratory infection harboring positive qPCR for respiratory virus (influenza A or B, RSV, rhinovirus, metapneumovirus) A pharyngeal and a nasal swabs will be performed for each patient. Culturomic and metagenomic analyses will be performed

Other: culturomic; Other: Metagenomic

asymptomatic patients

ACTIVE COMPARATOR

symptomatic patients with viral respiratory infection with positive qPCR for respiratory virus. A pharyngeal and a nasal swabs will be performed for each patient. Culturomic and metagenomic analyses will be performed

Other: culturomic; Other: Metagenomic

healthy subjects

OTHER

Control group of healthy patients. A pharyngeal and a nasal swabs will be performed for each patient. Culturomic and metagenomic analyses will be performed

Other: culturomic; Other: Metagenomic

Interventions

culturomic OTHER

Culturomic is a high-throughput culture strategy based on the multiplication of culture conditions coupled with the rapid identification of bacteria by MALDI-TOF (Matrix-Assisted Laser Desorption / Ionization-Time-Of-Flight) mass spectrometry

asymptomatic patients; healthy subjects; symptomatic patients

Metagenomic OTHER

Metagenomics is an high throughput sequencing and will be performed using Miseq ( Illumina technology) targeting the V3-V4 hypervariable regions of the 16S RNA gene.

asymptomatic patients; healthy subjects; symptomatic patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult \> 18 years
• Hospitalized patients with respiratory viral infection diagnosed by qPCR and / or rapid tests
• Contact cases (parent, sister, brother, ...) of patients presenting with viral respiratory infection
• No one has expressed opposition to the processing of personal data
• Person who had been informed and had not expressed his opposition to participate in the study

You may not qualify if:

• Minor patient
• Subject who take antibiotic in the 3 weeks before the viral respiratory infection
• Presence of another non-respiratory bacterial infection
• Vulnerable person: Minor, person under guardianship, or deprived of liberty by a judicial or administrative decision

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Des Hopitaux de Marseille

Marseille, PACA, 13005, France

Location

MeSH Terms

Interventions

malacidins

Study Officials

• EMILIE GARRIDO PRADALIE

  APHM

  STUDY DIRECTOR

Central Study Contacts

Sophie EDOUARD, MD

CONTACT

+33491385517; sophie.edouard@univ-amu.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2018
• First Posted: July 26, 2018
• Study Start: September 1, 2018
• Primary Completion: February 1, 2021
• Study Completion: October 1, 2021
• Last Updated: July 26, 2018

Record last verified: 2018-06

Locations

FR (1)