Effectiveness of Nifurtimox in Patients With Chagas' Disease Based on Data From Patient Medical Records in Argentina: a Retrospective Medical Chart Review Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Parasitological cure of adult patients with chronic Chagas' disease
研究概览
简要总结
The researchers in this trial want to analyze prerecorded patient data which provide information on benefits of the drug nifurtimox in patients with a sudden (acute) and long lasting (chronic) Chagas´ disease an illness caused by parasites mostly transmitted to humans by a bug. They also want to learn how often organs, especially the heart, are affected by the illness in treated and untreated chronic Chaga's patients. In order to find this out medical records of adult and pediatric patients in Argentina will be analyzed.
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
- 0 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients aged ≥0 years at time of diagnosis with Chagas' disease
- •Diagnosis of Chagas' disease confirmed by parasitological and/or serological method(s) before start of antitrypanosomal treatment or during the course of this antitrypanosomal treatment cycle for the first episode recorded.
排除标准
- •Treatment with antitrypanosomal agent(s) other than nifurtimox, including experimental investigational products for Chagas' disease or antitrypanosomal combination treatment
- •Patients with known evidence of organ manifestation of chronic Chagas' disease, e.g.Chagas' disease-related cardiomyopathy/heart disease, Chagas' disease-related digestive disease at time of primary diagnosis.
研究组 & 干预措施
Treatment
Patients diagnosed with acute and chronic Chagas' disease, respectively, who were treated with nifurtimox
干预措施: Lampit (Nifurtimox, BAYA2502) (Drug)
结局指标
主要结局
Parasitological cure of adult patients with chronic Chagas' disease
时间窗: Retrospective analysis from late 1960s to about 1980
Change in the laboratory test result for Chagas' disease to negative after treatment with nifurtimox and without antitrypanosomal treatment compared to baseline. Adults are defined as patients who were 18 years or older at the time of initial diagnosis of acute or chronic Chagas' disease
次要结局
- Parasitological cure of pediatric patients with acute and chronic Chagas' disease(Retrospective analysis from late 1960s to about 1980)
- Occurrence of cardiac manifestations in patients with chronic Chagas' disease(Retrospective analysis from late 1960s to about 1980)
- Treatment of Cardiomyopathy and/or Heart Failure(Retrospective analysis from late 1960s to about 1980)