Utility of Antibiotic Treatment in Acute Non-purulent Exacerbations of COPD: a Double Blinded, Randomized, Placebo-controlled Trial of Security and Efficacy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 73
- 试验地点
- 4
- 主要终点
- Efficacy of treatment WITHOUT antibiotics in non-purulent exacerbations of COPD
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Antibiotic
Patients will receive in a masked way, moxifloxacin.
干预措施: Moxifloxacin (Drug)
结局指标
主要结局
Efficacy of treatment WITHOUT antibiotics in non-purulent exacerbations of COPD
时间窗: Six months
次要结局
- In-hospital stay (days)(Six months)
- All cause mortality(One and Six months)
- Efficacy/Safety in treatment on re-hospitalizations at six months.(Six monts)
- Quality of Life (QoL) measured by the Saint George Respiratory Questionnaire(Hospitalization day 1 and six months)
研究者
Nestor Soler Porcar, MD, PhD
Especialista Senior
Fundacion Clinic per a la Recerca Biomédica
