跳至主要内容
临床试验/NCT06044051
NCT06044051
招募中
不适用

Dynamique Des Microbiomes Respiratoires Des Voies supérieures et inférieures associée à l'Asthme sévère Des Nourrissons

University Hospital, Rouen1 个研究点 分布在 1 个国家目标入组 100 人2023年9月26日

概览

阶段
不适用
干预措施
Blood sample
疾病 / 适应症
Asthma in Children
发起方
University Hospital, Rouen
入组人数
100
试验地点
1
主要终点
description of microbiomes from nasopharyngeal samples
状态
招募中
最后更新
2个月前

概览

简要总结

Nature of potential dysbiosis, interrelation of the different microbiomes of the respiratory tract, and potential role of the immune system in the pathogenesis of severe asthma in infants, and its evolution under treatment.

Exploring and understanding these data is to improve patient care and discover new therapeutic targets.

The aim is to open up prospects for therapeutic studies, such as the use of azithromycin as an immunomodulator in infant asthma, the results of which are discordant.

注册库
clinicaltrials.gov
开始日期
2023年9月26日
结束日期
2026年9月26日
最后更新
2个月前
研究类型
Interventional
研究设计
Single Group
性别
All

研究者

发起方
University Hospital, Rouen
责任方
Sponsor

入排标准

入选标准

  • Infants less than 24 months old
  • Follow-up by a pneumo-pediatrician for severe asthma in infants
  • Requiring etiological investigations and assessment of severity in day hospitalization, including bronchial fibroscopy (HAS 2009)
  • Parent informed of the research and having signed consent

排除标准

  • Prematurity \<32 WA
  • Congenital heart disease with significant left to right shunt
  • Chronic respiratory disease other than infant asthma (cystic fibrosis, bronchiolitis obliterans)
  • Antibiotic therapy in progress or administered the seven days preceding the date of inclusion (day hospitalization)
  • Refusal of bronchial fibroscopy

研究组 & 干预措施

All patients

All patients included will be followed for 1 year, every 3 months

干预措施: Blood sample

All patients

All patients included will be followed for 1 year, every 3 months

干预措施: Expectoration

All patients

All patients included will be followed for 1 year, every 3 months

干预措施: Nasopharyngeal swab

结局指标

主要结局

description of microbiomes from nasopharyngeal samples

时间窗: at 12 months

analysis of nasopharyngeal samples- NGS sequencing

Description of microbiomes from sputum samples

时间窗: at 12 months

analysis of sputum samples- NGS sequencing

description of microbiomes from bronchoalveolar fluids

时间窗: at 12 months

analysis of bronchoalveolar fluids- NGS sequencing

description of microbiomes from sputum samples

时间窗: at 9 months

analysis of sputum samples- NGS sequencing

description of microbiomes from bronchoalveolar fluids

时间窗: Inclusion

analysis of bronchoalveolar fluids - NGS sequencing

description of microbiomes from nasopharyngeal samples

时间窗: Inclusion

analysis of nasopharyngeal samples- NGS sequencing

description of microbiomes from sputum samples

时间窗: Inclusion

analysis of sputum samples- NGS sequencing

description of microbiomes from bronchoalveolar fluids

时间窗: at 3 months

analysis of bronchoalveolar fluids- NGS sequencing

description of microbiomes from nasopharyngeal samples

时间窗: at 3 months

analysis of nasopharyngeal samples- NGS sequencing

description of microbiomes from sputum samples

时间窗: at 3 months

analysis of sputum samples- NGS sequencing

description of microbiomes from bronchoalveolar fluids

时间窗: at 6 months

analysis of bronchoalveolar fluids- NGS sequencing

description of microbiomes from nasopharyngeal samples

时间窗: at 6 months

analysis of nasopharyngeal samples- NGS sequencing

description of microbiomes from sputum samples

时间窗: at 6 months

analysis of sputum samples- NGS sequencing

description of microbiomes from bronchoalveolar fluids

时间窗: at 9 months

analysis of bronchoalveolar fluids - NGS sequencing

description of microbiomes from nasopharyngeal samples

时间窗: at 9 months

analysis of nasopharyngeal samples- NGS sequencing

研究点 (1)

Loading locations...

相似试验