Comparator Trial Evaluating Microbiological Resistance and Clinical Efficacy in Patients Using Alternation Therapy of Inhaled Antibiotics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Antibiotic Resistance Profiles
研究概览
简要总结
This is a pilot study of inhaled antibiotic regimens is a pilot study examining clinical and laboratory endpoints of patients on inhaled antibiotic treatments. We hypothesize that alternation therapy utilizing Cayston and Tobi will inhibit antibiotic resistance and that alternation therapy will result in a decreased incidence of antibiotic resistance to Cystic Fibrosis (CF) microbial isolates. The long term strategic goal is to develop a model biometric system for selecting a patient's optimal inhaled antibiotic regimen by utilizing clinical and microbiological parameters.
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
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •> or = to 6 years of age
- •Documentation of Cf diagnosis
- •History of PA present in sputum, on a least one occasion, during the 12 months prior to Visit
- •Currently on inhaled antibiotic regiment
- •Must be able to provide written informed consent or assent prior to any study related procedures
- •Ability to expectorate sputum
- •Ability ro perform reproducible pulmonary function test
排除标准
- •Administration of any IV or oral antipseudomonal antibiotic within 28 days prior to Visit 1
- •Any serious or active medical or psychiatric illness, which in the opinion of the investigator, woud interfere with participant treatment, assessment, or compliance with the protocol
- •Current enrollment in an interventional clinical trial
结局指标
主要结局
Antibiotic Resistance Profiles
时间窗: Every three months within a 12 month period
The primary endpoint will be a change in the microbial resistance profile of pseudomonas aeruginosa (PA)isolates, change in PA sputum density, minimum inhibitory concentration of aztreonam and tobramycin for PA and the appearance or disappearance of other pathogens.
次要结局
- Clinical Symptoms(Every 3 months within a 12 month period)
研究者
Michelle Howenstine
Professor of Clinical Pediatrics
Indiana University