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临床试验/NCT02363764
NCT02363764已完成不适用

The Challenge of Obtaining Qualitative Bacterial Cultures in Non-expectorating Cystic Fibrosis Patients

Universitair Ziekenhuis Brussel0 个研究点目标入组 175 人开始时间: 2015年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
175
主要终点
Sensitivity, specificity, positive and negative predicted value

研究概览

简要总结

Accurate identification of lower respiratory tract pathogens is standard of care in the management of CF patients and it is therefore recommended to perform regular bacterial cultures, at least once a year, but some even recommend monthly cultures. This can be done through different methods, of which sputum and bronchoalveolar lavage (BAL) are the gold standard. However, BAL is an invasive method, not designated to repeat monthly. Therefore, the diagnosis of lower respiratory tract infections can be challenging in the non-expectorating CF patient. Other methods, such as induced sputum (IS), cough swabs and nasal swabs, have been developed to obtain bacterial cultures in these patients. Studies have investigated the reliability of these different sampling methods, however, with controversial conclusions.

详细描述

I. Protocol design:

The current protocol is designed to compare:

  • Group 1: nasal swab, cough swab and spontaneous expectorated sputum in expectorating CF patients
  • Group 2: nasal swab, cough swab and induced sputum in non-expectorating CF patients
  • Group 3: nasal swab, cough swab, induced sputum and BAL in both expectorating and non-expectorating CF patients requiring clinically indicated bronchoscopy

II. Flow chart:

  1. Nasal swab obtained by the physiotherapyst (PT)
  2. Patient rinses his mouth with water, followed by autogenic drainage
  3. Cough swab obtained by the PT
  4. Obtainment of 3rd (4th) sample:

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

  • Both expectorating and non-expectorating CF patients with confirmed diagnosis (sweat test / genotyping)
  • Attending the UZ Brussel CF Clinic
  • Written informed consent from each participant and/or his parents or legal guardian

排除标准

  • CF patients who underwent lung transplantation
  • Denial of participation to the study

结局指标

主要结局

Sensitivity, specificity, positive and negative predicted value

时间窗: 2 years

Sensitivity, specificity, positive and negative predicted value of different sampling methods

次要结局

  • Preference of method(Questionnaire: day of sampling, Analysis: 2 years)
  • Pain experienced with any method(Questionnaire: day of sampling, Analysis: 2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hanneke Eyns

Physiotherapist

Universitair Ziekenhuis Brussel

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