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临床试验/NCT04171583
NCT04171583已完成不适用

Characterisation of Mucoid Staphylococcus Aureus Recovered From the Airways of Cystic Fibrosis Patients: Prevalence and Impact on Clinical Course

University Hospital Muenster13 个研究点 分布在 2 个国家目标入组 628 人开始时间: 2019年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
628
试验地点
13
主要终点
lung function of patients with mucoid S. aureus will be compared to age and gender matched patients with only normal S. aureus

研究概览

简要总结

Recently, the investigators described a new mucoid phenotype of Staphylococcus aureus cultured from the airways of cystic fibrosis (CF) patients.In this observational study, the investigators plan to determine the prevalence of mucoid S. aureus in respiratory specimens of CF patients and a possible impact of mucoid S. aureus on lung disease severity.

详细描述

S. aureus is one of the first isolated pathogens recovered from the airways of CF patients. In many patients, S. aureus persists for decades in spite of antibiotic treatment and host defence. During persistence in the airways, S. aureus needs to adapt to this hostile niche. Just recently, the investigators described mucoid S. aureus isolates as a so far not reported phenotype recovered from the airways of CF patients. These mucoid isolates carried a 5bp-deletion in a part of the "intercellular adhesion operon (ica) leading to hyper-expression of biofilm. So far, neither the prevalence of mucoid S. aureus nor the impact on lung disease in CF patients is known. The investigators plan to perform a clinical study to determine the prevalence of mucoid S. aureus isolates in a cross-sectional study and the impact of identified mucoid S. aureus on the clinical course of the lung disease by observing patients with mucoid S. aureus for 12 months in comparison with a group of age-, gender- and P. aeruginosa-positive/negative matched group of S. aureus-positive patients without mucoid isolates.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • CF patients with chronic S. aureus in respiratory specimens (50% positive S. aureus cultures within one or two years before recruitment)

排除标准

  • 未提供

结局指标

主要结局

lung function of patients with mucoid S. aureus will be compared to age and gender matched patients with only normal S. aureus

时间窗: one year

lung function assessed by FEV1% predicted, which is performed during the visits at the cystic fiboris center, will be reported in case report forms to the investigator

次要结局

未报告次要终点

研究者

发起方
University Hospital Muenster
申办方类型
Other
责任方
Principal Investigator
主要研究者

Barbara Kahl

Professor

University Hospital Muenster

研究点 (13)

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