Tobramycin 300 mg o.d. Aerosol in in Adult Patients With Cystic Fibrosis: Pilot Study on Antimicrobial Activity
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Evaluation of bacterial load decrease
研究概览
简要总结
The study will include 10 adult patients with cystic fibrosis. The aim of the study is to evaluate whether Tobramycin 300 mg aerosol once-a-day for 28 days can reduce the bacterial load in the airways. Secondary end-point is the evaluation of variation in bacterial susceptibility during and at the end of study period.
详细描述
Ten adult patients with cystic fibrosis will be enrolled in a stable phase and will received prophylaxis with aerosol of Tobramycin 300 mg once a day for 28 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients, male and female, age range 18-45 years
- •Diagnosis of cystic fibrosis
- •FEV1 >50% predicted.
- •sputum samples available
- •Chest x ray negative for pneumonia and tuberculosis
- •Informed consent
排除标准
- •Allergy to tobramycin
- •Use of systemic steroids in the previous 2 weeks
- •Pregnancy or breast feeding
- •Treatment with other experimental drug in the previous 3 months
研究组 & 干预措施
inhaled tobramycin once-a-day
Adult patients, with cystic fibrosis, requiring inhaled tobramycin prophylaxis. Patient will be treated with a single dose of 300 mg tobramycin od for 28 days.
干预措施: tobramycin (Drug)
结局指标
主要结局
Evaluation of bacterial load decrease
时间窗: day 7-9 vs day 1, day 14-16 vs day 7-9, day 28-30 vs day 14-26
Bacterial load in sputum will be evaluated during and at the end of treatment
次要结局
- Evaluation of inflammatory serum biomarker(day7-9 vs day 1, Day 14-16 vs day 7-9, Day 28-30 vs 14-16)
- Evaluation of serum biomarker(day7-9 vs day 1, Day 14-16 vs day 7-9, Day 28-30 vs 14-16)
- evaluation of serum biomarker(day7-9 vs day 1, Day 14-16 vs day 7-9, Day 28-30 vs 14-16)
研究者
Francesco Blasi
Professor of respiratory medicine
University of Milan