NCT00005668已完成2 期
A Multicenter, Prospective, Randomized, Double-Blind Clinical Trial Comparing Itraconazole Oral Solution in Cyclodextrin to Placebo in the Treatment of Aspergilloma
National Institute of Allergy and Infectious Diseases (NIAID)2 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2001年8月31日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 2
研究概览
简要总结
To compare the safety and effectiveness of itraconazole oral solution to placebo in the treatment of a pulmonary aspergilloma.
Aspergilloma is a "fungal ball" in the lungs caused by Aspergillus. The infection can spread from the lungs through the blood to other organs. Aspergilloma can be life-threatening; therefore, an effective treatment is needed.
详细描述
Patients are randomly selected to receive itraconazole oral solution by mouth or the inactive placebo (oral cyclodextrin solution) twice daily for 12 months.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- Double
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
- •You may be eligible for this study if you:
- •Are 18 years of age or older.
- •Have been diagnosed with aspergilloma within the last month.
- •Have (or have a history of) at least one of the following:
- •positive test for Aspergillus species.
- •presence of antibodies to Aspergillus.
- •Are willing to participate in the study for 2 full years.
- •Are female and not pregnant.
- •Are not breast-feeding.
- •Agree to use barrier methods of birth control / contraception during the study and for 30 days after.
排除标准
- •You will not be eligible for this study if you:
- •Have a history of allergy to triazole or imidazole drugs.
- •Are unable to take oral medication.
- •Are not expected to live for more than a month.
- •Have had a lung biopsy indicating Aspergillus infection.
- •Have had radiation therapy within the last 6 months.
- •Require treatment with certain medications.
- •Received amphotericin, amphotericin lipid formulation, fluconazole, or itraconazole in the two weeks prior to study entry.
- •Received chemotherapy within the last 6 months.
研究者
研究点 (2)
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