临床试验/NCT00598897

NCT00598897已完成4 期

Open, Noncomparative Trial of Multidrug Regimens Containing Clarithromycin and Rifabutin Administered Three Times Per Week for the Treatment of M. Avium Complex (MAC) Lung Disease

The University of Texas Health Science Center at Tyler1 个研究点分布在 1 个国家目标入组 89 人开始时间: 1995年8月最近更新: 2017年5月23日

适应症

干预措施

试验速览

阶段: 4 期
状态: 已完成
发起方: The University of Texas Health Science Center at Tyler
入组人数: 89
试验地点: 1
主要终点: Clinical and microbiological outcomes such as clinical symptoms and laboratory cultures

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

To determine the safety and tolerance of clarithromycin given three times per week in combination with multiple drugs including rifabutin three times per week

详细描述

Safety and tolerance of clarithromycin given 3 times weekly with multiple drugs including ethambutol and rifampin/rifabutin

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 mycobacterial 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 mycobacterial or fungal lung pathogens (except for the coexistence of M. abscessus).
•Adults age 18 and older
•Pretreatment isolate of M. avium complex available for MIC determination

排除标准

•History of allergy to study drugs
•If a mensruating female, not pregnant and on adequate birth control.
•Children less than 18 years of age
•HIV + or at high risk for HIV infection.

研究组 & 干预措施

clarithromycin and rifabutin/rifampin

Experimental

Clarithromycin and rifabutin/rifampin with ethambutol given three times weekly.

干预措施: clarithromycin, rifabutin (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

sputum conversion culture neg x3

次要结局

Clinical and microbiological outcomes(1 yr)

研究者

发起方

The University of Texas Health Science Center at Tyler

申办方类型

Other

责任方

Principal Investigator

主要研究者

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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