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临床试验/NCT03600753
NCT03600753Unknown不适用

Characterization of Respiratory Microbiota in Susceptibility to Viral Respiratory Infections Using Metagenomic and Culturomic Approach

Assistance Publique Hopitaux De Marseille2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年9月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
2
主要终点
culturomic

研究概览

简要总结

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.

详细描述

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.

The precise characterization of the respiratory microbiota in patients with viral respiratory infections is still incomplete. Our work is original because it will combine innovative and complementary techniques of culturomics and metagenomics for the exhaustive study of the respiratory microbiota associated with respiratory viral disease.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

culturomic

时间窗: 30 months

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.

Bacterial metagenomics

时间窗: 30 months

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)

standard microbiological diagnosis of virology

时间窗: 30 months

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

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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