Nifurtimox Versus Benznidazole Effectiveness and Tolerance for Chagas Disease Treatment, Retrospective Cohort
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 900
- 试验地点
- 1
- 主要终点
- Nifurtimox versus Benznidazole serologic, parasitemia and clinical response for treatment in patients
研究概览
简要总结
Chagas disease is caused by parasite Trypanosoma Cruzi. In Argentina, there is an estimated of 1.600.000 infected people. Due to migration phenomenon, most cases live in urban areas without vectorial transmission.
Pharmacological treatment is given to prevent development of cardiac and gastrointestinal sequelae. There are two available drugs for this disease; Nifurtimox and Benznidazole. They both has proven efficacy for acute face treatment, with different security profiles. There are not enough adequate studies comparing both drugs made in a large number of subjects. Investigators will study 900 patients treated with both drugs and compare security and efficacy in a retrospective cohort.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between 0 and 18 years of age with confirmed Chagas disease (defined as patients under 8 months with positive parasitemia or older with 2 positive different techniques for serology) that received treatment with Nifurtimox or Benznidazole.
排除标准
- •Patients that abandoned follow-up
结局指标
主要结局
Nifurtimox versus Benznidazole serologic, parasitemia and clinical response for treatment in patients
时间窗: Patients treated from 1984 to 2017
To compare Nifurtimox versus Benznidazole treatment efficacy, by measuring serologic response, parasitemia and clinical manifestations in infected patients
次要结局
- Nifurtimox versus Benznidazole security and tolerance(Patients treated from 1984 to 2017)
- To compare Chagas disease characteristics associated with treatment(Patients treated from 1984 to 2017)
研究者
Dr Jaime Altcheh
PHD MD
Hospital de Niños R. Gutierrez de Buenos Aires