Corticoids in Severe Community-acquired Pneumonia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- Rate of non-response to empiric antimicrobial treatment
研究概览
简要总结
The purpose of this study is to assess the efficacy of glucocorticoids as an adjuvant therapy in patients with severe community-acquired pneumonia (CAP) (Fine V). The hypothesis of the study is that glucocorticoids can modulate the excessive inflammatory response in patients with severe CAP without any significant side effects, showing a benefit in the percentage of non-response to the empiric antimicrobial treatment.
详细描述
Community acquired pneumonia (CAP) is associated with a local and systemic inflammatory response conducted by different pro and counter inflammatory cytokines. The evolution of the infection is mainly dependent on the intensity of the inflammatory response. The AIM of the project is to determine the clinical usefulness of methylprednisolone treatment (0,5 mg/ Kg weight every 12h for 5 days in patients with severe CAP and an excessive inflammatory response( patients identified based on a cut-off point of the reactive C protein (RCP) of 15 mg/dl). A randomized double blind placebo controlled study with two arms will be performed: The study group (patients with excessive inflammatory response) will receive methylprednisolone + antibiotics. Control group will receive placebo + antibiotics. Patients older than 18 years with Fine V pneumonia will be recruited. Clinical data and prognostic factors (APACHE II and, SOFA scores, etiology, mortality at ICU and at 28 days) will be collected.
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
- •Severe community-acquired pneumonia Fine V
- •CRP >=15 mg/100 mL
排除标准
- •Major contraindications for corticosteroids, such as uncontrolled diabetes, immunosuppression
- •Previous glucocorticoid treatment during the previous month
- •Documented extrapulmonary infection
- •Previous hospitalization in the previous month
研究组 & 干预措施
methylprednisolone
methylprednisolone 0.5 mg/kg body weight every 12 h for 5 days
干预措施: methylprednisolone (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Rate of non-response to empiric antimicrobial treatment
时间窗: 5 days
次要结局
未报告次要终点
研究者
Carlos Agusti
Consultor Senior
Hospital Clinic of Barcelona
