Low-dose CT for Diagnosis of Pneumonia in COPD Exacerbations and Comparison of the Inflammatory Profile.
Assessment of the Degree of Pneumonia Underdiagnosis in Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Using Chest Low-dose Computed Tomography (CT) and Comparison of Inflammatory Profile Between the Two Entities
* Hypothesis: There is an underdiagnosis of pneumonia in COPD (Chronic Obstructive Pulmonary Disease) exacerbations which could be demonstrated by performing low-dose chest CT. Differences in the inflammatory profile in sputum and blood in patients with and without pneumonia can be seen.
* Objective: To assess the degree of underdiagnosis of pneumonia in COPD exacerbations, using chest low-dose CT and to compare clinical and inflammatory differences in blood and sputum between patients with and without pneumonia.
*Material and Methods: Prospective observational study including 75 patients with the diagnosis of COPD at the time of an exacerbation and with criteria for a respiratory tract infection. At the time of inclusion clinical features, blood and sputum analysis, chest X-ray and chest low-dose CT are performed. The investigators divide the patients into two groups according to the existence of pneumonia and the inflammatory pattern in blood (inflammatory markers) and sputum (cell populations and inflammatory markers) is compared between the two branches.
研究概览
地位
条件
研究类型
注册 (预期的)
联系人和位置
学习地点
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Barcelona、西班牙、08041
- 招聘中
- Hospital De La Santa Creu I Sant Pau
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接触：
- Sebastian
- 邮箱：lsebastian@santpau.cat
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副研究员：
- Laura Sebastian, MD
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副研究员：
- Tomas Franquet, MD PhD
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副研究员：
- Ana M Giménez, MD
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
INCLUSION CRITERIA
- clinical and spirometric diagnosis of COPD.
- for study group: clinical symptoms of exacerbation and infection of low airway.
- Signed informed consent.
EXCLUSION CRITERIA
- No acceptance of informed consent.
- The STUDY GROUP: treatment with antibiotic more tan 2 days before consultation.
- Another entity known pulmonology other than COPD (non-obstructive disorders, bronchiectasis, interstitial lung disease patients, severe pulmonary hypertension, hypoventilation).
- Chronic treatment with oral corticosteroids or immunosuppressive drug.
- severe organ comorbidity such as cancer in advanced or terminal phase, pulmonary tuberculosis with important involvement, severe pneumoconiosis.
- Severe alteration of nutritional status.
- Heart disease evolved.
- Limitation for understanding the study (including psychiatric disorder, language problem, social or cultural differences, etc.).
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
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COPD exacerbation
No intervention. The subjects will be divided in 2 subgroups according to the image study:
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COPD stable patients
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
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Number of patients with an exacerbation of their disease who have a Pneumonia diagnosed by low dose - CT (not detected by chest X-Ray).
大体时间：1 year and a half
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1 year and a half
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合作者和调查者
调查人员
- 首席研究员：Ingrid Solanes, MD PhD、Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- IIBSP-EPO-2013-152
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
慢性阻塞性肺病恶化的临床试验
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Bangabandhu Sheikh Mujib Medical University, Dhaka...完全的
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Virginia Commonwealth UniversityFisher and Paykel Healthcare完全的
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University College, LondonUniversity of Cambridge; National Institute for Health Research, United Kingdom; Royal Free Hampstead...未知
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