Santeon-CAP; Dexamethasone in Community-acquired Pneumonia.
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 413
- 试验地点
- 4
- 主要终点
- Length of hospital stay
研究概览
简要总结
The present study is designed to investigate the beneficial effects of adjunctive dexamethasone therapy in patients admitted with community-acquired pneumonia, additionally aiming at assessing what patients benefit from dexamethasone treatment mostly. A large multicenter study will be conducted comparing a 4 days dexamethasone 6 mg per os course with placebo in 600 patients and with predefined subgroup analyses planned.
详细描述
Community-acquired pneumonia (CAP) is a common infection. Approximately 20 percent of all episodes of pneumonia result in hospitalization. It is the leading cause of community-acquired infection requiring intensive care unit (ICU) admission. In pulmonary infections, the release of cytokines and other inflammatory mediators from alveolar macrophages serves as a mechanism by which invading pathogens are eliminated. However, this reaction of the innate immune system can be potentially harmful when excessive release of circulating inflammatory cytokines causes damage to the patient, particularly the lung. Interest in the role of corticosteroids in the pathophysiology of critical illness has existed since the early part of the 20th century. On ICU, early treatment with corticosteroids to attenuate systemic inflammation is widespread. At the same time, outside the ICU little evidence is available on the effect of treatment with corticosteroids in patients diagnosed with CAP. Theoretically, early initiated administration of corticosteroids in the course of a CAP can lower systemic and pulmonary inflammation. This may lead to earlier resolution of pneumonia and a reduction of complications (sepsis, mortality).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •Chest radiograph showing new opacities.
- •In combination with two of the following findings:
- •Production of sputum
- •Temp >38,0 °C or <36,0 °C
- •Audible abnormalities by chest examination compatible with pneumonia
- •Leukocytosis (>10.000 cells/mm3), leftward shift (>10%) or leucopenia (<4000 cells/mm3)
- •C-reactive protein > 15 mg/l (three fold higher than the upper limit of normal)
排除标准
- •Immunocompromised patients:
- •Patients with a known congenital or acquired immunodeficiency.
- •Patients who received chemotherapy less than 6 weeks ago.
- •Patients who received corticosteroids in the last 6 weeks.
- •Patients who received immunosuppressive medication in the last 6 weeks (e.g. cyclosporin, cyclophosphamide, azathioprine).
- •Patients with chronic obstructive pulmonary disease who are on systemic corticosteroids.
- •Patients who require intensive care unit treatment.
- •Patients with tropical worm infection.
- •Patients with dexamethasone intolerance.
- •Pregnant and breastfeeding women.
研究组 & 干预措施
Dexamethasone
干预措施: Dexamethasone (Drug)
Placebo
Placebo tablet, once daily for four consecutive days
干预措施: Placebo (Drug)
结局指标
主要结局
Length of hospital stay
时间窗: Hospital admission (= day 1 = timepoint at which patient presents in hospital) until hospital discharge; participants will be followed for the duration of hospital stay, an expected average of 1 week.
Discharge date will be the date on which the patient is clinically ready to be discharged (which means days of hospital stay on basis of social indication will be excluded from analyses). Median length of stay in an earlier CAP study performed in the St. Antonius Hospital in Nieuwegein was 6.5 days, thus patients will be followed during an expected average of 1 week.
次要结局
- ICU admission(hospital admission (=day 1) until hospital discharge; participants will be followed for the duration of hospital stay, an expected average of 1 week.)
- Mortality(day 30)
研究者
Dr. WJW Bos
Principal Investigator
St. Antonius Hospital