NCT01390012已完成3 期
Oral Versus Intravenous Dexamethasone in Community-Acquired Pneumonia
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Area Under the Concentration time curve
研究概览
简要总结
The purpose of this study is to assess bioequivalence for dexamethasone administered orally versus intravenously in patients admitted to hospital for pneumonia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Aged 18 years and older
- •Presenting to the emergency room with suspected pneumonia (to be confirmed within 24 hours from admission) Pneumonia is defined as a new or progressive infiltrate on a chest X-ray plus at least two of the following criteria: cough, sputum production, temperature >38°C or <35°C, auscultatory findings consistent with pneumonia, leucocytosis or leucopenia (>10 g/l, <4 g/l or >10% rods in leucocyte differentiation), C-reactive protein >3 times the upper normal limit Corticosteroid naive at time of presentation
排除标准
- •Patients needing corticosteroid treatment above study medication
- •Failure to obtain written consent to participate
- •Patients using medication drugs that interact with dexamethasone (i.e. phenytoin, barbiturates, rifampicin, erythromycin, clarithromycin, aprepitant, colchicine, everolimus, itraconazole, ketoconazole, pazopanib, tipranavir, and vinorelbine)
- •Moribund patients (defined as expected to die within 24 hours)
- •Patients with proven or suspected allergy to dexamethasone
- •Patients not capable of taking tablets orally
研究组 & 干预措施
Dexamethasone oral
Active Comparator
干预措施: Dexamethasone tablet 6 mg (Drug)
Dexamethasone intravenous
Active Comparator
干预措施: Dexamethasone injection 4 mg (Drug)
结局指标
主要结局
Area Under the Concentration time curve
时间窗: 0-24 hours
次要结局
未报告次要终点
研究者
E.M.W. van de Garde, PharmD
Dr.
St. Antonius Hospital
研究点 (1)
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