EUCTR2013-004420-11-BE进行中（未招募）1 期
Azithromycin for acute COPD exacerbations with hospitalisation: the BACE trial - BACE
KU Leuven - UZ Leuven0 个研究点目标入组 301 人开始时间: 2014年2月13日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 301
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1/ Established diagnosis of COPD by medical doctor (based on clinical history OR pulmonary function test)
- •2/ Smoking history (= 10 pack-years)
- •3/ Current hospitalization for potential infectious AECOPD treated with standard therapy
- •4/ History of at least one exacerbation during the last year for which systemic steroids and/or antibiotics were taken
- •5/ ECG at admission
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 300
排除标准
- •1/ Mechanical or non-invasive ventilation at moment of randomisation (D1)
- •2/ Long QT interval on ECG (QTc > 450msec for males or > 470msec for females)
- •3/ History of life-threatening arrhythmias
- •4/ Myocardial infarction (NSTEMI or STEMI) less than 6 weeks before of start study
- •5/ Unstable angina pectoris or acute myocardial infarction (NSTEMI or STEMI) at admission
- •6/ Drugs with high risk for long QT interval and torsade de pointes
- •(amiodarone, flecainide, procainamide, sotalol, droperidol, haldol, citalopram, other macrolides).
- •7/ Documented uncorrected severe hypokalemia (K+ < 3.0 mmol/L) or hypomagnesemia (Mg2+ <0.5 mmol/L)
- •8/ Chronic systemic steroids (> 4 mg methylprednisolone /day for = 2 months)
- •9/ Actual use of macrolides for at least 2 weeks
- •10/ Allergy to macrolides
- •11/ Active cancer treatment
- •12/ Life expectancy < 3 months
- •13/ Pregnant or breast-feeding women
研究者
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