NCT00952861撤回4 期
Antibiotic Treatment of Patients Admitted to Hospital With Acute Exacerbation of COPD. Effect of 1 Day of Antibiotic Therapy Compared to 6 Days of Therapy in Patients Who Are Stable After 24 Hours
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- 6 minutes walking distance
研究概览
简要总结
It is not clear whether antibiotic therapy is needed in patients with mild to moderate exacerbation of chronic obstructive lung disease. The aim of the study is to compare the effect of 1 day of treatment with 6 days of treatment in patients who are admitted to hospital and being clinical stable (as judged by their physician) 24 hours after hospitalization
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age above 50 years
- •History of smoking
- •History of COPD
- •Antibiotics for 24 hours
- •At least 2 of the following: dyspnoea, coughing with sputum, and sputum with purulence
- •Informed consent
排除标准
- •Pneumonia
- •Antibiotics for more than 36 hours
- •Antibiotics for other infection
- •Prednisolone, more than 0.5 mg/kg body weight/24 hours for more than 3 days
- •Malignancy
- •Other pulmonary disease
- •Immune deficiency
- •Not able to tolerate doxycycline
- •Severe heart, liver or kidney disease
- •Epilepsia
- •Not stable 24 hours after hospital admission
- •Need for assisted ventilation
研究组 & 干预措施
Doxycycline
Active Comparator
Doxycycline 200 mg QD in 5 days
干预措施: Doxycycline (Drug)
Placebo
Placebo Comparator
Matching placebo QD i 5 days
干预措施: Placebo (matching) (Drug)
结局指标
主要结局
6 minutes walking distance
时间窗: Day 14
次要结局
- Time to next episode of acute exacerbation(Days 14, 30, 90 and 180)
研究者
研究点 (1)
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