Prospective Randomized Trial Comparing Oral Ciproxin Plus Inhaled Colistin With Tobramycin for Inhalation for Eradication of P Aeruginosa Infection in Children With Cystic Fibrosis.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Pseudomonas aeruginosa eradication at the end of the treatment.
研究概览
简要总结
Treatment of new Pseudomonas aeruginosa (Pa) infection in cystic fibrosis (CF) can postpone chronic infection. Aim of the study: compare 2 Pa eradication regimens in children with new Pa infection.
详细描述
Methods: CF children (0-18 years) with a new isolation of Pa from the airway were randomized to tobramycin inhalation solution (TOBI® 2x300 mg for 28 days) (TIS) or inhaled colistimethate sodium (Colistineb® 2x2 mill U daily) plus oral ciprofloxacin (30mg/kg/day) for 3 months (CC). The primary outcome was eradication at end of treatment. Secondary outcome parameters were time to Pa relapse, total and Pa specific IgG, FEV1, BMI and Pa status.
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
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of CF (clinical signs consistent with CF and a sweat chloride > 60 mEq/l by quantitative pilocarpine iontophoresis and/or two CF causing mutations identified)
- •age 0 to 18 years old at time of inclusion
- •'First' or 'new Pa infection' defined as 'first Pa isolation ever' or 'isolation of Pa from the airway (sputum, throat swab or BAL) after a Pa free interval of at least 6 months and documented with at least 3 negative cultures'.
排除标准
- •chronic Pa infection defined according to the Leeds criteria[17]
- •pulmonary exacerbation needing IV AB treatment at time of new Pa isolate
- •Pa isolation at time of CF diagnosis
- •patient already on an antipseudomonal antibiotic
- •interval between positive culture and start of treatment > 4 weeks.
研究组 & 干预措施
Ciproxin-inhaled Colistin
oral ciprofloxacin (30mg/kg/day) plus inhaled colistimethate sodium (Colistineb® 2x2 mill U daily) for 3 months
干预措施: oral ciprofloxacin plus inhaled colistin (Drug)
Tobramycine for inhalation (TIS)
tobramycin inhalation solution (TOBI® 2x300 mg) for 28 days
干预措施: TOBI (Drug)
结局指标
主要结局
Pseudomonas aeruginosa eradication at the end of the treatment.
时间窗: end of study drug treatment ie 3 months for CC and at 1 months for TIS
sucessful eradication is defined as negative airway culture for P aeruginosa and end of study drug which is after 3 months for ciproxin-colistin (CC) and after 1 months for tobramycin for inhalation (TIS)
次要结局
- P aeruginosa eradication at 6 months after study entry(6 months)
- time to new Pa positive culture (= relapse)(1 year)
- change from baseline FEV1% pred, IgG z score, BMI z score was followed(1 year)
- Antibody titer for specific anti Pseudomonas antibodies(1 year)
- P aeruginosa infection status(2 years)