NCT00378495终止1 期
Miltefosine for Brazilian Visceral Leishmaniasis
AB Foundation1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2005年4月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- cure rate at 6 months
研究概览
简要总结
Miltefosine will be administered to Brazilian patients with kala azar
详细描述
Miltefosine will be administered to Brazilian patients with kala azar. Both pediatric and adult patients will be studied. Patients will be followed for 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed (untreated) visceral leishmaniasis with symptomatic disease and visualization of amastigotes in tissue samples or a positive culture.
- •Age: Group 1: 2 to 12 years; Group 2: 13 to 60 years
- •Sex: male and female patients eligible (no effort to be made to balance the study for gender)
排除标准
- •Exclusion criteria
- •Safety concerns:
- •Thrombocyte count <30 x 109/l;
- •Leukocyte count <1 x 109/l;
- •Hemoglobin <5 g/100 ml;
- •ASAT, ALAT, AP >3 times upper limit of normal range;
- •Serum creatinine or BUN >1.5 times upper limit of normal range;
- •Evidence of serious underlying disease (cardiac, renal, hepatic or pulmonary);
- •Immunodeficiency or antibody to HIV;
- •Severe protein and/or caloric malnutrition (Kwashiorkor, Marasmus);
- •Any non-compensated or uncontrolled condition;
- •Lactation, pregnancy (to be determined by adequate test) or inadequate contraception in females of childbearing potential for treatment period plus 2 months.
- •Lack of suitability for the trial:
- •Negative bone marrow aspirate (smear);
- •Any history of prior anti-leishmania therapy;
- •Any condition which compromises ability to comply with the study procedures;
- •Concomitant serious infection other than visceral leishmaniasis (this would include evidence of other conditions associated with splenomegaly such as schistosomiasis or malaria).
- •Administrative reasons:
- •Lack of ability or willingness to give informed consent (patient and/or parent / legal representative);
- •Anticipated non-availability for study visits/procedures.
结局指标
主要结局
cure rate at 6 months
次要结局
- cure rate at 1 month
- safety
研究者
研究点 (1)
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