Continuous-infusion Anti-pseudomonal β-lactams for the Treatment of Acute, Infective Pulmonary Exacerbations in Cystic Fibrosis

The Alfred1 个研究点分布在 1 个国家目标入组 50 人开始时间: 2012年9月最近更新: 2017年4月20日

适应症

干预措施

试验速览

阶段: 4 期
发起方
入组人数: 50
试验地点: 1
主要终点: Cystic Fibrosis Questionnaire-Revised respiratory component (CFQ-R) respiratory symptom score

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Cystic fibrosis (CF) is an inherited disorder which results in increased thickness of secretions, especially in the lungs. By adulthood, the majority of patients with CF will have a bacteria living in their lungs, called Pseudomonas aeruginosa which can cause lung infections. This usually results in worsening respiratory symptoms and often an acute deterioration in their lung function. They are usually treated with antibiotics that target the Pseudomonas aeruginosa. These antibiotics are typically given as short intravenous infusions several times a day. This study aims to compare the standard method of giving these antibiotics with a different strategy of giving these antibiotics to see if this can improve the outcomes of treatment of these infections and reduce the amount of Pseudomonas aeruginosa in the lungs of these patients. This strategy consists of giving the same antibiotics continuously, to ensure there is always enough antibiotic in the bloodstream and the lung to be able to kill the bacteria.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Treatment
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

•Patients >= 18 years of age,
•Pseudomonas aeruginosa isolated in sputum within the last 12 months,
•has an acute infective exacerbation, defined by international standards of 2 or more of the following in the last 2 weeks:
•change sputum volume or colour,
•increased cough,
•increased dyspnoea,
•increased malaise, fatigue or lethargy,
•anorexia or weight loss,
•decrease in pulmonary function by 10% or more, or
•new radiographic changes

排除标准

•patients < 18 yrs of age,
•patients that do not meet the criteria for an acute infective exacerbation,
•concurrent pulmonary embolism, significant haemoptysis, pneumothorax, or respiratory failure,
•impaired renal function with an estimated creatinine clearance < 60 mls/min,
•patients allergic to ß-lactam antibiotics,
•aminoglycoside contra-indicated,
•intravenous antibiotics in the last 2 weeks, prior to this admission,
•received more than 24 hours of intravenous antibiotics in this admission,
•previous lung transplantation,
•pregnancy or lactation, or
•inability to consent.

研究组 & 干预措施

Intermittent, short infusion

Active Comparator

Infusion over 30 minutes of either:

Cefepime 1g q8/24 OR Ceftazidime 2g q8/24 OR Meropenem 1g q8/24 OR Piperacillin-Tazobactam 4.5g q8/24 OR Ticarcillin-clavulanate 3.1g q6/24