Corticosteroid Treatment for Community-Acquired Pneumonia A Randomized, Double-blind Study- The STEP Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 800
- 试验地点
- 7
- 主要终点
- Time to clinical stability
研究概览
简要总结
Background: An intact hypothalami-pituitary-adrenal (HPA) axis with an effective intracellular anti-inflammatory activity of glucocorticoids is indispensable for host survival during stress upon exposure to an infectious agent. Community-acquired pneumonia (CAP) is characterized by significant mortality and increased circulating inflammatory cytokines. Despite adequate antimicrobial therapy mortality rates for CAP have not changed over several decades. The use of corticosteroids in patients with CAP is inconclusive.
Study aim: To compare a 7 days treatment with prednisone and placebo in patients with community-acquired pneumonia with respect to time to clinical stability.
Study hypothesis: The investigators hypothesize that use of corticosteroids will lead to a 25% relative risk reduction for death and clinical instability.
Study type: randomized double blind intervention study
Patients: 800 patients with community-acquired pneumonia
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Patients 18 years of age or older admitted for hospitalization from the community or a nursing home with CAP.
- •CAP will be defined by a new infiltrate on chest radiograph and the presence of one or several of the following acute respiratory signs or symptoms:
- •sputum production
- •core body temperature >38.0° C
- •auscultatory findings of abnormal breath sounds and rales
- •leukocyte count >10 or <4 x 109 cells L-1 (1)
排除标准
- •Patients or family members unable to give written informed consent, e.g. with severe dementia.
- •Patients with active intravenous drug use.
- •Severe immunosuppression (e.g. patients infected with human immunodeficiency virus infection and a CD4 count below 350 x 109/L, patients on immunosuppressive therapy after solid organ transplantation and neutropenic patients with neutrophil count < 500 x 109/L and patients under chemotherapy with neutrophils 500-1000 x 109/L with an expected decrease to values < 500 x 109/L); patients with cystic fibrosis as well as patients with active tuberculosis.
- •Patients with acute burn injury
- •Patients with acute gastrointestinal bleeding within 3 months of the current hospitalization
- •Patients with an acute concomitant condition requiring more than 0.5mg/kg/d prednisone equivalent
- •Pregnancy or breast feeding
- •Patients with known adrenal insufficiency
研究组 & 干预措施
Prednisone
Drug
干预措施: Prednisone (Drug)
Placebo
干预措施: Prednisone (Drug)
结局指标
主要结局
Time to clinical stability
时间窗: 30 days
次要结局
- Side effects of corticosteroids, mortality, recurrence(30 days)
研究者
Mirjam Christ-Crain
Prof. Dr. med. Leitende Aerztin
University Hospital, Basel, Switzerland