Evaluation of an Antibiotic Treatment With 14 Days of Intravenous Tobramycin Versus the Same Antibiotic Associated With 5 Days of Intravenous Tobramycin Followed by Tobramycin Aerosol for 9 Days in Cystic Fibrosis.
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 23
- 试验地点
- 7
- 主要终点
- Forced expiratory volume at one second (FEV1) by spirometry
研究概览
简要总结
The aim of this study is to investigate the efficacy of antibiotic therapy with any antibiotic (IV) and IV (Nebcin®) tobramycin for 5 days followed by Solution for nebuliser inhalation (Tobi®) for 9 days and antibiotic cures using 14 days of tobramycin IV. In the case of positive results, the reduction of the duration of IV treatment of tobramycin from 14 days to 5 days would limit the risk of toxicity.
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
- 8 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with cystic fibrosis confirmed by sweat or genetic test
- •Patient with clinical signs of exacerbation (increased cough, sputum (abundance, purulence), fever, anorexia, weight loss and FEV1) or acute exacerbations (defined at the clinician's discretion )
- •FEV1 ≥ 25%
- •Pseudomonas aeruginosa chronic carriers (defined by at least two antipyocyanic precipitation arcs or at least 3 successive positive ECBCs over a period of 18 months)
- •Patient who received at least 1 IV course of antibiotics in the 18 months prior to inclusion.
排除标准
- •Severe exacerbation (requiring hospitalization due to severe amputation of FEV 1, oxygen deficiency, or severe impairment of general health).
- •Patient with 3rd antibiotic therapy (triple therapy)
- •Patient colonized in Burkholderia cepacia
- •Patient colonized by an atypical mycobacterium
- •Patient with pulmonary transplant or transplant
- •chronic tinnitus
- •patient using hearing aid
- •Hypersensitivity to tobramycin and other antibiotics of the aminoglycoside family
- •Cirrhosis of Grades B and C according to the Child-Pugh Classification
- •Myasthenia gravis
- •Simultaneous administration of another aminoglycoside
- •Renal failure
- •Recent history of severe hemoptysis (within 2 months before inclusion)
- •Patient participating simultaneously in another clinical study conducted on a drug for the duration of its participation in this research
研究组 & 干预措施
Standard cure
Antibiotic IV (Nebcin) 14 days and 14 days of tobramycin IV associated with one or more other antibiotic (s) IV in routine care
干预措施: Tobi Inhalant Product (Drug)
Standard cure
Antibiotic IV (Nebcin) 14 days and 14 days of tobramycin IV associated with one or more other antibiotic (s) IV in routine care
干预措施: Nebcin (Drug)
Short cure
antibiotic IV (Nebcin)14 days but with only 5 days of tobramycin IV followed 9 days of inhaled tobramycin (Tobi Inhalant Product) associated with one or more other antibiotic (s) IV in routine care
干预措施: Tobi Inhalant Product (Drug)
Short cure
antibiotic IV (Nebcin)14 days but with only 5 days of tobramycin IV followed 9 days of inhaled tobramycin (Tobi Inhalant Product) associated with one or more other antibiotic (s) IV in routine care
干预措施: Nebcin (Drug)
结局指标
主要结局
Forced expiratory volume at one second (FEV1) by spirometry
时间窗: 18 months of the cure
measure of dyspnea
次要结局
- Visual Analog Scale(baseline and between day 16 or day 22)
- Number of pulmonary exacerbations and those leading to hospitalization(during 18 months)
- number of participants with Bronchial congestion(baseline and between day 16 or day 22)
- Occurrence of the first exacerbation after the cure(during 18 months)
- Sputum sample culture(baseline and between day 16 or day 22)
- Forced expiratory volume at one second (FEV1) by spirometry(baseline and between day 16 or day 22)