Comparative Evaluation of Bacterial Diversity and Richness in CF Lung in Patients Who Use Cycled Every Other Month Tobramycin Inhalation Powder (TOBI™ Podhaler™) Or Continuous Alternating Therapy With Tobramycin Inhalation Powder (TOBI™ Podhaler™) and Inhaled Colistimethate
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Simpson Diversity Index
研究概览
简要总结
The purpose of this study is to characterize bacterial diversity and richness in the sputum of cystic fibrosis patients treated with every-other-month TOBI™ Podhaler™ and continuous alternating therapy with TOBI™ Podhaler and colistimethate (Colistin).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of cystic fibrosis confirmed by mutation analysis of the cystic fibrosis transmembrane conductance regulator gene
- •Sputum or throat swab culture positive for Pseudomonas aeruginosa at or within 6 months of enrollment
- •Age ≥12 years
- •Forced expiratory volume in one second (FEV1) 25-90 percent-predicted
排除标准
- •Age <18 years
- •Inability to routinely expectorate sputum without induction by hypertonic saline
- •Inability to provide or withdrawal of written informed consent
- •History of aminoglycoside sensitivity or adverse reaction to inhaled antibiotics
- •Serum creatinine ≥ 2.0 mg/dl
- •Serum blood urea nitrogen (BUN) ≥40 mg/dl
- •Pregnancy or lactating at screening
- •History of systemic intravenous anti-Pseudomonal antibiotics within 28 days of enrollment
研究组 & 干预措施
Continuous Therapy
TOBI™ Podhaler™ 112 mg inhaled by mouth twice daily for 30 days followed by a 30-day cycle colistimethate 75 mg inhaled two times daily. Repeat cycle.
干预措施: TOBI™ Podhaler™ 112 mg inhaled twice daily (Drug)
Continuous Therapy
TOBI™ Podhaler™ 112 mg inhaled by mouth twice daily for 30 days followed by a 30-day cycle colistimethate 75 mg inhaled two times daily. Repeat cycle.
干预措施: Colistimethate 75 mg inhaled two times daily (Drug)
Cyclic therapy
TOBI™ Podhaler™ 112 mg inhaled by mouth twice daily for 30 days followed by a 30-day period during which no inhaled antibiotics are used. Repeat cycle.
干预措施: TOBI™ Podhaler™ 112 mg inhaled twice daily (Drug)
结局指标
主要结局
Simpson Diversity Index
时间窗: 6 months
The primary estimate in our study is the mean effects of Continuous Alternating Therapy compared to Cyclic therapy on Simpson Diversity Index (SDI) averaged at month 6
次要结局
- Bacterial Relative Abundance(6 months)
研究者
Alex H. Gifford
Assistant Professor of Medicine
Dartmouth-Hitchcock Medical Center