NCT01162967已完成2 期
PROTOCOL FOR PHASE II CLINICAL TRIAL, RANDOMIZED AND OPEN FOR ETIOLOGICAL TREATMENT OF CHRONIC CHAGAS DISEASE WITH POSACONAZOLE AND BENZNIDAZOLE
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 3
- 主要终点
- Parasitological cure measured by a real time PCR in blood sample
研究概览
简要总结
The investigators propose the evaluation of posaconazole and benznidazole in humans for the treatment of Chagas disease chronical infection. Exploratory trial of posaconazole antiparasitic activity against Trypanosoma cruzi.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Consenting patients with serological evidence of Chagas infection and positive PCR real time
排除标准
- 未提供
研究组 & 干预措施
Benznidazole
Active Comparator
干预措施: Benznidazole (Drug)
Posaconazole, low dose
Experimental
干预措施: Posaconazole (Drug)
Posaconazole, high dose
Experimental
干预措施: Posaconazole (Drug)
结局指标
主要结局
Parasitological cure measured by a real time PCR in blood sample
时间窗: 12 months after starting treatment
PCR negative at the end of follow up
次要结局
- Parasitological cure measured by real time PCR in blood sample(End of treatment, weeks 8, 16, 24 and 40 after treatment)
- Safety and tolerability of both drugs(First 2 months)
研究者
研究点 (3)
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