Phase II Clinical Trial for the Evaluation of Different Benznidazole Regimens for the Treatment of Chronic Chagas Disease in Adult Patients. Berenice Project
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 238
- 试验地点
- 7
- 主要终点
- Proportion of patients with negative parasitaemia measured by PCR during the first 12 months after starting treatment
研究概览
简要总结
A phase 2 clinical trial to evaluate the the efficacy of different benznidazole regimens (300mg/day for 60 days, 150mg/day for 60 days, and 400mg/day for 15 days) for the treatment of chronic Chagas disease in adult patients. The efficacy is assessed through the proportion of patients with negative parasitaemia measured by Polymerase Chain Reaction (PCR) during the first 12 months after starting treatment. The study will be performed in Spain, Brazil, Argentina and Colombia.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Over 18 years old.
- •Diagnosis of Chagas disease through two different serological tests.
- •Positive T. cruzi PCR in peripheral blood.
- •Signed informed consent.
排除标准
- •Previous treatment with Benznidazole or Nifurtimox.
- •Alcohol consumption.
- •Acute or chronic health problems that could interfere in the assessment of the efficacy or safety of the drug (acute infections, HIV infection, liver or renal impairment, etc).
- •Nitroimidazole hipersensitivity.
- •Concomitant or previous treatment with allopurinol or antifungal drugs.
- •Pregnancy.
研究组 & 干预措施
B300/60
Benznidazole 300mg/day p.o. divided in two doses for 60 days
干预措施: Benznidazole (Drug)
B150/60
Benznidazole 150mg/day p.o. divided in two doses for 60 days
干预措施: Benznidazole (Drug)
B400/15
Benznidazole 400mg/day p.o. divided in two doses for 15 days
干预措施: Benznidazole (Drug)
结局指标
主要结局
Proportion of patients with negative parasitaemia measured by PCR during the first 12 months after starting treatment
时间窗: 12 months
The treatment efficacy is assessed through the proportion of patients with negative parasitaemia measured by PCR during the first 12 months after starting treatment
次要结局
未报告次要终点