Antibiotic or Not in Non-purulent Exacerbations of COPD: a Trial of Security and Efficacy (AEPOC-ATB)
Utility of Antibiotic Treatment in Acute Non-purulent Exacerbations of COPD: a Double Blinded, Randomized, Placebo-controlled Trial of Security and Efficacy
COPD is one of the most important causes of morbidity and mortality and supposes a sanitary problem in Europe and USA. Patients with COPD usually have 1-2 episodes of acute exacerbation of COPD (AECOPD) per year, being these the principal causes of of hospitalizations, respiratory problems and medical visits. After an episode of AECOPD, the majority of patients develop a transitory (or permanent) worsening in their quality of life and 50% of them will require a new hospitalization. Globally, a 75%& of the exacerbations might be associated with a respiratory tract infection, and among them, 50% might be related to bacteria and in 45% an evidence of viral infection could be documented. Even though the antibiotic treatment might not be useful for a majority of patients with AECOPD, is generalized its use(almost an 85% in some series) in hospitalized patients. The non-controlled use of antibiotics in AECOPD results in a very expensive disease and raises the rate of resistance of bacteria. The available literature have shown that there's a relation between exacerbations and infections, based on sputum samples.
In summary, is well known that at least a 50% of the episodes of AECOPD might be associated with pathogenic bacteria in the lower respiratory tract. Prescription of antibiotics is wide and generalized in hospitalized patients. Clinical trials have shown correlation between AECOPD with sputum purulence (which correlates with presence of bacteria), however they've not included NON-purulent AECOPD, even though they're a significative group of patients hospitalized by this cause too. It's necessary to evaluate the efficacy nor the security of antibiotic treatment in this group of patients in a well designed trial.
研究概览
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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Barcelona、西班牙、08006
- Hospital Clínica Platón
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Aragon
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Zaragoza、Aragon、西班牙、50009
- Hospital Miquel Servet
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Catalonia
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Barcelona、Catalonia、西班牙、08036
- Fundacio Clinic Per la Recerca Biomèdica - Hospital Clinic de Barcelona
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Comunitat Valenciana
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Valencia、Comunitat Valenciana、西班牙、46009
- Fundació La Fe- Hospital La Fe
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- COPD diagnosis according to GOLD guidelines
- Hospitalization for any acute exacerbation of chronic obstructive pulmonary disease
- Failure of outpatient treatment
- Increasing of dyspnea in the last days
- Comorbidity that causes detriment of respiratory function
Exclusion Criteria:
- Life expectancy of less than 6 months
- Mechanical Ventilation
- Cardiovascular condition that causes exacerbation
- Immunosuppression
- Pulmonary infiltrates that suggest pneumonia
- Antibiotic treatment in the last month
- Pregnancy
- ECG with a large QT segment
- Hypokalemia
- Hepatic failure or renal failure
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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无干预:Non-Antibiotic
Patients will not receive antibiotics, although the study is double-blind.
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有源比较器:Antibiotic
Patients will receive in a masked way, moxifloxacin.
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Moxifloxacin 400 mg administered once a day for 5 days
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Efficacy of treatment WITHOUT antibiotics in non-purulent exacerbations of COPD
大体时间:Six months
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Six months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Efficacy/Safety in treatment on re-hospitalizations at six months.
大体时间:Six monts
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Six monts
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In-hospital stay (days)
大体时间:Six months
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Six months
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All cause mortality
大体时间:One and Six months
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One and Six months
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Quality of Life (QoL) measured by the Saint George Respiratory Questionnaire
大体时间:Hospitalization day 1 and six months
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This item will be measured by the application of the Saint George Respiratory Questionnaire (SGRQ)
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Hospitalization day 1 and six months
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合作者和调查者
调查人员
- 首席研究员:Nestor Soler, MD,PhD、Hospital Clinic of Barcelona
出版物和有用的链接
一般刊物
- Connors AF Jr, Dawson NV, Thomas C, Harrell FE Jr, Desbiens N, Fulkerson WJ, Kussin P, Bellamy P, Goldman L, Knaus WA. Outcomes following acute exacerbation of severe chronic obstructive lung disease. The SUPPORT investigators (Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments). Am J Respir Crit Care Med. 1996 Oct;154(4 Pt 1):959-67. doi: 10.1164/ajrccm.154.4.8887592. Erratum In: Am J Respir Crit Care Med 1997 Jan;155(1):386.
- Murray CJ, Lopez AD, Black R, Mathers CD, Shibuya K, Ezzati M, Salomon JA, Michaud CM, Walker N, Vos T. Global burden of disease 2005: call for collaborators. Lancet. 2007 Jul 14;370(9582):109-110. doi: 10.1016/S0140-6736(07)61064-2. No abstract available.
- Snow V, Lascher S, Mottur-Pilson C; Joint Expert Panel on COPD of the American College of Chest Physicians and the American College of Physicians-Amercian Society of Internal Medicine. The evidence base for management of acute exacerbations of COPD: clinical practice guideline, part 1. Chest. 2001 Apr;119(4):1185-9. doi: 10.1378/chest.119.4.1185. No abstract available.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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