Phase II Study of Amithiozone (Thiacetazone) for Patients With Mycobacterium Avium Complex Pulmonary Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
研究概览
简要总结
OBJECTIVES: I. Determine the bacteriological activity of amithiozone against Mycobacterium avium complex (MAC) pulmonary disease.
II. Define the ability of amithiozone to improve clinical outcomes in patients with MAC infection.
III. Determine the safety and tolerance of amithiozone with chronic dosing in these patients.
IV. Assess the contribution of clarithromycin, streptomycin, rifampin, ethambutol, kanamycin, and amithiozone in the treatment of pulmonary MAC infection.
详细描述
PROTOCOL OUTLINE: The is a randomized, open label study. All patients receive a core regimen of clarithromycin and streptomycin. Patients are randomized into two treatment arms. Arm I patients receive rifampin and ethambutol. Arm II patients receive amithiozone.
Patients are followed for one year to detect any relapse or other complications.
Patients not eligible for this randomized study may be entered on a short open label study with amithiozone.
Completion date provided represents the completion date of the grant per OOPD records
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •PROTOCOL ENTRY CRITERIA:
- •-Disease Characteristics--
- •Progressive pulmonary disease due to Mycobacterium avium complex (MAC) as defined by: Three of more sputum culture(s) positive for MAC Change in serial chest roentgenograms consistent with active mycobacterial disease over a 12 week period No other obvious cause of pulmonary disease
- •Patients must have organisms that are: Susceptible to amithiozone AND Susceptible or moderately susceptible to the combination of rifampin and ethambutol, and to clarithromycin and streptomycin
- •-Prior/Concurrent Therapy--
- •No likelihood of resectional thoracic surgery within 24 weeks of evaluation
- •-Patient Characteristics--
- •Age: 18 and over
- •Performance status: Not specified
- •Hematopoietic: Not specified
- •Hepatic: Bilirubin less than 3 times normal SGOT/SGPT less than 3 times normal Alkaline phosphatase less than 3 times normal
- •Renal: Creatinine clearance at least 30 mL/min
- •Cardiovascular: No New York Heart Association class III or IV heart failure
- •Other: No optic disease that precludes the use of ethambutol No hypersensitivity to rifampin, ethambutol, clarithromycin, streptomycin, or amithiozone HIV negative Not pregnant or nursing
排除标准
- 未提供