Hypertonic Saline for Treatment of Pulmonary Mycobacterium Avium Complex (MAC) Disease
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Culture conversion
研究概览
简要总结
The MAC-HS study is a testing whether hypertonic saline helps improve symptoms and clearance of mycobacteria in patients with M. avium complex lung infections.
详细描述
The MAC-HS study is an open label, randomized control trial of hypertonic saline in pulmonary M. avium complex patients. Eligible patients who consent to participate will be randomized 1:1 to hypertonic saline or standard of care for 12 weeks. All patients in the treatment group will take inhaled hypertonic saline twice daily for 12 weeks. Patients may continue with other airway clearance methods (i.e. flutter, acapella valve, aerobika, postural drainage, huff cough, percussion). Patients may also be treated with antibiotics targeted at other pathogens if an exacerbation occurs. Patients may also be actively treated with inhaled corticosteroid at the time of enrollment, with dosing adjustments during the trial discouraged. Patients with disease progression at any time can be discontinued from the study treatment and treated according to ATS/IDSA guidelines at the discretion of the primary investigator. However, such patients will still complete the 12 week final visit, sputum collection and AE assessment.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 2 positive MAC sputum cultures in the last 12 months with at least one AFB positive sputum obtained within 12 weeks prior to randomization
- •Meet American Thoracic Society (ATS)/ Infectious Disease Society of America (IDSA) 2007 pulmonary clinical disease criteria[1]
- •Age 18 and older
- •Diagnosis of Bronchiectasis and/or bronchiectatic findings evident on chest CT report
- •Ability to provide informed consent
排除标准
- •Any patient who is unwilling or unable to provide consent or to comply with this protocol
- •Cavitary NTM disease
- •Patients who are currently taking or within the prior 6 months received any of the following: bedaquiline, or any component of ATS/IDSA multi-drug recommended therapy (macrolide, ethambutol, rifampin) for MAC treatment
- •Diagnosis of HIV
- •Diagnosis of Cystic fibrosis
- •Active pulmonary tuberculosis, fungal, or nocardial disease requiring treatment at screening
- •Current use of chronic systemic corticosteroids at doses of 15 mg/day for more than 3 months
- •Prior lung or other solid organ transplant
研究组 & 干预措施
Hypertonic saline
Patients who randomize to the hypertonic saline arm will be prescribed a nebulizer device to nebulize hypertonic saline (7%) twice daily for 12 weeks. Hypertonic saline (3%) can be prescribed in the case of poor tolerability of the 7% solution.
干预措施: Hypertonic saline (Drug)
Standard of Care
Patients who randomize to the standard of care arm will receive treatment for pulmonary MAC based on the approved ATS/IDSA guidelines. Changes to standard of care regimen may be made based on the investigator's discretion.
干预措施: Azithromycin (Drug)
Standard of Care
Patients who randomize to the standard of care arm will receive treatment for pulmonary MAC based on the approved ATS/IDSA guidelines. Changes to standard of care regimen may be made based on the investigator's discretion.
干预措施: Ethambutol (Drug)
Standard of Care
Patients who randomize to the standard of care arm will receive treatment for pulmonary MAC based on the approved ATS/IDSA guidelines. Changes to standard of care regimen may be made based on the investigator's discretion.
干预措施: Rifampin (Drug)
结局指标
主要结局
Culture conversion
时间窗: 12 weeks
At least two negative AFB cultures on different days.
次要结局
- Semi-quantitative culture results(12 weeks)
研究者
Kevin Winthrop
Principal Investigator
Oregon Health and Science University