NCT01044719Unknown4 期
What Duration of Intravenous Antibiotic Therapy Should be Used in the Treatment of Infective Exacerbations of Cystic Fibrosis Chronically Colonised With Pseudomonas Aeruginosa
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Treatment failure at completion of antibiotic course
研究概览
简要总结
Cystic Fibrosis patients attending with infective exacerbations will be enrolled into the study. The trial is a double blinded, randomised trial with patients randomised to 10,14 or 21 days of antibiotic therapy, comprising of tobramycin and either ceftazidime or meropenem.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •16 years or older
- •Diagnosis of Cystic Fibrosis
- •Presenting with Infective exacerbation
排除标准
- •Unable to give consent
- •Allergy to study medications
- •Intolerance of aminoglycoside antibiotics
- •Pseudomonas resistant to study antibiotics
- •On the active transplant list or FEV1<20% predicted
- •Pregnancy/breast-feeding
- •Co-existent ABPA requiring a change in treatment
- •Co-existent mycobacterial infection
- •A previous participant in the study
研究组 & 干预措施
10 days
Active Comparator
干预措施: Ceftazidime (Drug)
10 days
Active Comparator
干预措施: Tobramycin (Drug)
10 days
Active Comparator
干预措施: Meropenem (Drug)
14 days
Active Comparator
干预措施: Ceftazidime (Drug)
14 days
Active Comparator
干预措施: Tobramycin (Drug)
14 days
Active Comparator
干预措施: Meropenem (Drug)
21 days
Active Comparator
干预措施: Ceftazidime (Drug)
21 days
Active Comparator
干预措施: Tobramycin (Drug)
21 days
Active Comparator
干预措施: Meropenem (Drug)
结局指标
主要结局
Treatment failure at completion of antibiotic course
时间窗: 21 days
Time to next exacerbation
时间窗: 6 months
次要结局
- Change in Spirometry(up to 21 days)
- Change in inflammatory markers(up to 21 days)
- Change in sputum bacteriology(up to 21 days)
- Adverse effects of study antibiotics(Up to 21 days)
- Quality of life scores(Up to 21 days)
- Change in nutritional status(up to 21 days)
研究者
研究点 (1)
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