NCT00002159已完成3 期
A Randomized, Open, Comparative Multicenter Study of Initial Treatment With Intravenous Itraconazole Versus Amphotericin B Followed by Consolidation Treatment With Itraconazole Capsules in Patients With Blastomycosis or Histoplasmosis
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Janssen, LP
- 入组人数
- 60
- 试验地点
- 9
研究概览
简要总结
To assess the safety of intravenous itraconazole compared to amphotericin B in HIV positive or negative persons with blastomycosis or histoplasmosis.
详细描述
Patients are randomized to receive IV itraconazole for 2 days, then either itraconazole daily for 5 days or amphotericin B daily for 7 days. IV treatment is followed by consolidation with oral itraconazole for up to 1 year.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have:
- •HIV positive or negative status.
- •Blastomycosis or histoplasmosis.
- •Life expectancy of at least 1 week.
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms or conditions are excluded:
- •Liver disease.
- •Self-limiting fungal disease.
- •Very severe fungal disease such as meningeal involvement.
- •Acute respiratory disease.
- •Concurrent Medication:
- •Excluded at any time:
- •Terfenadine.
- •Astemizole.
- •Oral midazolam.
- •Triazolam.
- •Cisapride.
- •Phenytoin.
- •Phenobarbital.
- •Rifampin.
- •Rifabutin.
- •Excluded during oral consolidation:
- •H2 blockers.
- •Chronic antacids.
- •Omeprazole.
- •Lansoprazole.
- •Patients with the following prior condition are excluded:
- •Hypersensitivity to azole antifungals.
- •Prior Medication:
- •Excluded at any time:
- •More than 3 days of amphotericin B, fluconazole, or ketoconazole.
- •Excluded within 2 weeks prior to study entry:
- •Phenytoin.
- •Phenobarbital.
- •Rifampin.
- •Rifabutin.
研究者
研究点 (9)
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