NCT00002085已完成不适用
A Study to Evaluate the Safety and Efficacy of Azithromycin in Individual Patients With Serious Nontuberculous Mycobacterial Disease Who Are Failing or Intolerant of Other Available Therapy
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 试验地点
- 2
研究概览
简要总结
To evaluate the efficacy and safety of azithromycin given chronically for the treatment of serious nontuberculous mycobacterial infection in patients failing or intolerant of other available therapy.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 1 Day 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Concurrent Medication:
- •Other antimicrobial drugs as long as documented on Case Report Form.
- •Patients must have:
- •Serious nontuberculous mycobacterial infection.
- •Approval of eligibility from Pfizer Clinical Monitor. Patients below the legal age of consent must have consent of parent or guardian.
- •Pregnant women, women of childbearing potential, and children will not be specifically excluded from participation. However, patients and physicians should be aware that the safety of azithromycin during pregnancy and in long-term use in children and adults has not been established. The risks and benefits of azithromycin use in these patients will be considered in consultation with the physician and the Pfizer Clinical Monitor.
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms or conditions are excluded:
- •Disseminated Mycobacterium avium complex (MAC) who are eligible for treatment with azithromycin under protocol 066-
- •Known hypersensitivity or intolerance to macrolide antibiotics.
- •Patients with the following prior conditions are excluded:
- •History of hypersensitivity or intolerance to azithromycin.
研究者
研究点 (2)
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