NCT00600769已完成4 期
Open Study of Clarithromycin for the Treatment of Infections Caused by Nontuberculous Mycobacteria (NTM)
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
- 210
- 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
Use of oral clarithromycin for treatment of chronic lung disease due to Mycobacterium avium-intracellulare and other non-tuberculous Mycobacteria
详细描述
Oral clarithromycin for treatment of MAC and other nontuberculous mycobacteria in adults with clinical history
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; absence of other potential lung pathogens (except for the coexistence of M. abscessus)
- •Age 18 years and older
排除标准
- •History of macrolide allergy
- •Must not receive the antihistamines terfenadine (Seldane) or astemizole (Hismanal) while on clarithromycin
- •Children less than 18 years of age
- •If a menstruating female, not pregnant and on adequate birth control
研究组 & 干预措施
treatment of MAC and other NTM
Other
Clarithromycin drug given twice daily.
干预措施: Clarithromycin (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 culture 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)
Loading locations...
相似试验
已完成
不适用
The Safety and Effectiveness of Clarithromycin in the Prevention of Mycobacterium Avium Complex (MAC) Infection in HIV-Infected PatientsMycobacterium Avium-intracellular InfectionHIV InfectionsNCT00002336Abbott
已完成
不适用
An Open-Label Study of the Use of Azithromycin in Patients With Symptomatic Disseminated Mycobacterium Avium-Intracellulare Complex (MAC) Infection Failing Current TherapyMycobacterium Avium-Intracellulare InfectionHIV InfectionsNCT00002089Pfizer
已完成
4 期
Intravenous Clarithromycin in Septic SyndromeVentilator Associated PneumoniaSepsisNCT00297674University of Athens200
已完成
4 期
Azithromycin in the Treatment of M. Avium Complex Lung DiseaseMycobacterium Avium Complex Lung DiseaseNCT00599079The University of Texas Health Science Center at Tyler66
Unknown
3 期
Clarithromycin Prophylaxis in Preterm Infants Colonisation With Ureaplasma Urealyticum and Mycoplasma HominisBronchopulmonary DysplasiaNCT01652118Zekai Tahir Burak Women's Health Research and Education Hospital250