NCT00598962已完成4 期
Open, Noncomparative Trial of Multidrug Regimens Containing Azithromycin and Rifabutin Administered Three Times Per Week for the Treatment of M. Avium Complex (MAC) Lung Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Clinical and microbiological outcomes such as clinical symptoms and laboratory cultures
研究概览
简要总结
To determine the safety and efficacy of azithromycin, rifabutin and ethambutol given three times weekly in the treatment of lung infection with M. avium complex(MAC)
详细描述
Azithromycin given 3 times weekly along with rifampin/rifabutin and ethambutol for treatment of MAC
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Meet American Thoracic Society criteria for nontuberculous lung disease: two or more AFB smear positive, culture positive sputums or bronchoscopic samples and/or two or more AFB smear negative respiratory samples with moderate to heavy growth (2+-4+); abnormal CXR consistent with M. avium lung disease; abnormal CXR consistent with M. avium lung disease; absence of other lung pathogens (except for the coexistence of M. abscessus).
- •Age 18 and older
- •Pretreatment isolate of M. avium complex available for MIC determination
- •Baseline laboratory and clinical testing for baseline CBC, Chemistry (including liver enzymes), hearing test, visual acuity and color discrimination
- •Available for long term followup
排除标准
- •History of macrolide or rifamycins allergy
- •Laboratory evidence of mycobacterial resistance to azithromycin
- •Children less than 18 years of age
- •If a menstruating female, not pregnant and on adequate birth control
- •HIV+ or at risk
研究组 & 干预措施
azithromycin and rifabutin/rifampin
Experimental
Azithromycin and rifabutin/rifampin administered three times weekly.
干预措施: Azithromycin (Drug)
azithromycin and rifabutin/rifampin
Experimental
Azithromycin and rifabutin/rifampin administered three times weekly.
干预措施: Rifabutin/rifampin (Drug)
结局指标
主要结局
Clinical and microbiological outcomes such as clinical symptoms and laboratory cultures
时间窗: 6 months
neg cultures X3 ( sputum conversion)
次要结局
- Microbiological cultures(1yr)
研究者
Richard J. Wallace, Jr., M.D.
Chairman Department of Microbiology
The University of Texas Health Science Center at Tyler
研究点 (1)
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