Burden of Hospitalized Pneumonia and Its Clinical Characteristics in Korea COPD Population: A Prospective, Multi-center, Cohort Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 384
- 试验地点
- 4
- 主要终点
- The distribution of pathogens in hospitalized pneumonia patients with COPD
研究概览
简要总结
Chronic obstructive pulmonary disease (COPD) is one of the leading causes of morbidity and mortality worldwide. By 2030, COPD is expected to be the fourth main cause of death. Community-acquired pneumonia (CAP) represents not only a frequent complication but also a deadly cause in COPD patients. Inhaled corticosteroids, which are frequently used among COPD patients increase the risk for pneumonia. The effect of pneumococcal conjugate vaccine 13 (PCV13) on the prevention of pneumococcal pneumonia among COPD patients in Korean population has not been studied yet.
Several factors such as multi-lobar pneumonia, Pseudomonas aeruginosa pneumonia, and high pneumonia severity are related to poor outcome of patients with COPD and pneumonia. Prior pneumococcal vaccine has a beneficial effect on outcomes of pneumonia with COPD patients. However, the effects of pneumococcal vaccine on the clinical outcome of COPD patients were evaluated mainly on 23-valent pneumococcal polysaccharide vaccine (PPV23). The beneficial effects of PPV23 rapidly fade out after inoculation, which is more prominent in old age group. In this sense, PPV23 vaccine is not sufficient in preventing pneumococcal diseases in COPD patients because COPD is the disease of old ages and mortality rate increases exponentially with advancing age. Pneumococcal conjugate vaccine 13 (PCV13) can overcome the waning phenomenon by the production of memory B cells. Although PCV13 is expected to be the best option for the prevention of pneumococcal pneumonia in COPD patients, there are few available studies supporting it.
In this study, we will conduct prospective, multi-center trial with the collaboration of Korean pulmonologists in five university-affiliated hospitals. In this study, we will evaluate influenza and pneumococcal vaccination status, the pathogen distribution, pneumonia severity, and clinical outcomes of hospitalized pneumonia patients with COPD.
If successfully accomplished, this study will enhance the awareness of the preventive use of PCV13 in COPD patients among Korean pulmonologists and, most importantly, it will lead to protection of more COPD patients from pneumococcal pneumonia, one of the most frequent and deadly complication.
详细描述
- Objectives; Prospective evaluation of distribution of pathogens and its clinical characteristics in hospitalized pneumonia patients with COPD
- SUBJECTS AND CENTERS A. Subjects; COPD patients hospitalized for community-acquired pneumonia from Feb, 2017 to Feb, 2018.
B. Centers; More than five university-affiliated hospitals of Korea 3. OTHER THERAPY; Treatment for COPD with pneumonia will be done by the disposal of attending physicians of each hospital. 4. STUDY DESIGN
; prospective, multi-center, cohort study 5. STUDY ANALYSIS A. The required number of COPD patients hospitalized for community-acquired pneumonia
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The sample size calculations were based on detecting 1 point difference in CURB-65 score between influenza/pneumococcal vaccine recipients and non-recipients (expecting the mean CURB-65 score of 3 points for influenza/pneumococcal vaccine recipients and 4 points for non-recipients), assuming a common standard deviation of 1 point in each group,* a two-tailed test at 5% type I error, and a desired power of 80%. In terms of PCV 13, the estimated sample size for an independent t-test is 90 when we expect that 10% of them were PCV13 recipients and the other 90% were non-recipients (in Korea, 10% of candidates are estimated to be vaccinated with PCV13). Since the CURB-65 scores may not be symmetrically distributed, adding 15% to the required number was considered for a non-parametric test and the desired number of patients with COPD and pneumococcal pneumonia is 104 for the analysis. Total 384 COPD patients admitted for community-acquired pneumonia will be enrolled, assuming 30% prevalence of pneumococcal pneumonia among them (the prevalence of pneumococcal pneumonia is 25~45% in Korea), with allowance of 10% possible data loss.
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referenced from 'Role of Semi-quantitative Serum Procalcitonin in Assessing Prognosis of Community Acquired Bacterial Pneumonia Compared to PORT PSI, CURB-65 and CRB-65 Journal of Clinical and Diagnostic Research. 2015 Jul, Vol-9(7): OC01-OC04' B. Parameters to be evaluated A) Demographic data . Age, gender, BMI, smoking status, socioeconomic status B) Past medical history
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
The distribution of pathogens in hospitalized pneumonia patients with COPD
时间窗: 1 year
次要结局
- Age- and gender-matched pneumonia severity(1 year)
- Mechanical ventilation rate(1 year)
- Intensive care unit (ICU) admission rate(1 year)
- The length of ICU stay(1 year)
- The length of hospital stay(1 year)
- Mortality(1 year)
研究者
JAE YEOL KIM
Professor
Chung-Ang University Hosptial, Chung-Ang University College of Medicine