Individualizing Corticosteroid Use in Pneumonia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Adherence to individual treatment rule and CRP-guided corticosteroid treatment
研究概览
简要总结
In this study, researchers propose a unique (individualized) approach to steroid treatment seeking to give the right dose of steroid to the right patient and at the right time. This study seeks to compare usual care to an individualized steroid dosing strategy by testing a marker of inflammation in the blood called C- reactive protein (CRP). The overall goal is to reduce an individual's exposure to steroids and the risk of potential side effects thereby increasing the potential benefit of using steroids to control inflammation in 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
- None
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
- •Hospitalized adult (≥ 18 years) patients.
- •Community acquired pneumonia.
排除标准
- •Contraindications or unwillingness to use corticosteroids by patient or provider.
- •History of adrenal insufficiency, septic shock, or another absolute indication for steroid use.
- •Suspected pulmonary vasculitis or other autoimmune pulmonary disorder.
- •Positive pregnancy test
- •Comfort care.
研究组 & 干预措施
Individualized dosing strategy
Biomarker guided corticosteroid use. Initiation of corticosteroid will be recommended based on the an individual treatment rule (ITR) and subsequent dosing of corticosteroid will be recommended based on daily CRP values till CRP <50 mg/L (according to a prespecified C-reactive protein-guided dosing algorithm). Corticosteroid dose and duration were determined by serial CRP measurements
The approved protocol included CRP-guided corticosteroid dosing as a prespecified contingency strategy if a clinically actionable individualized treatment rule could not be developed. The trial therefore proceeded with the CRP-guided corticosteroid strategy
干预措施: Dexamethasone (Drug)
Usual Care Group
Usual care as determined by the patient's primary team. Initiation and daily dosing of corticosteroid treatment will be based on clinicians' preference and clinicians.
结局指标
主要结局
Adherence to individual treatment rule and CRP-guided corticosteroid treatment
时间窗: First 5 days of hospitalization or until hospital discharge (whichever is sooner)
Number of eligible subjects that adhered to the timely initiation and daily corticosteroid treatment
次要结局
- In-hospital Disease Progression(First 5 days of hospitalization or until hospital discharge (whichever is sooner))
- Need for Advanced Respiratory Support(First 5 days of hospitalization or until hospital discharge (whichever is sooner))
- ICU and hospital free days(First 5 days of hospitalization or until hospital discharge (whichever is sooner))
- Advanced respiratory support free days(First 5 days of hospitalization or until hospital discharge (whichever is sooner))
- Mortality(First 5 days of hospitalization or until hospital discharge (whichever is sooner))
研究者
Yewande Odeyemi, MD
Principal Investigator
Mayo Clinic