The Efficacy and Safety of a Short Course of Miltefosine and Liposomal Amphotericin B for Visceral Leishmaniasis in India
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Final Cure six months after the end of treatment
研究概览
简要总结
Miltefosine and liposomal amphotericin B (AmBisome) are approved drugs for visceral leishmaniasis. In this study both drugs will be given in a sequential manner. AmBisome will be given on day 1, followed by Miltefosine for 14 days. Final Cure will be evaluated at six months.
详细描述
Methodology Multicenter trial, eligible patients will be treated with Liposomal amphotericin B (5 mg/kg) on day 1 and then with miltefosine capsules for 14 days (days 2-15).
At two weeks after the end of treatment the initial cure (clinical and parasitological cure) and the clinical response will be determined. If initial cure is observed, a patient will be evaluated after a 6 months (after end of treatment) follow up period for final clinical cure.
Number of patients planned Total number of patients planned: 150 patients at both centers combined. 75 pediatric (2-11 years); 75 adult (12-65 years).
Lack of suitability for the trial:
- Post Kala-azar Dermal Leishmaniasis (PKDL)
- Concomitant treatment with other anti-leishmanial drugs
- Any condition which compromises ability to comply with the study procedures
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
- •Male and female age between 2 and 65 years (inclusive)
- •Parasites visualized on splenic aspiration
- •Signs and symptoms compatible with visceral leishmaniasis (e.g. fever, splenomegaly, anaemia, weight loss, leucopenia, thrombocytopenia)
- •Confirmed diagnosis of VL by visualization of parasites on splenic/bone marrow aspirate
- •Fever for at least 2 weeks
- •Written informed consent from the patient/or from parent or guardian if under 18 years old
排除标准
- •Hemoglobin < 6 g/dl
- •White blood cell count < 1000/mm3
- •Platelets <50,000
- •Prothrombin time > 5 sec above control
- •ASAT > 3 times the upper limit of normal
- •Serum creatinine or BUN > 1.5 times the upper limit of normal
- •Tuberculosis
- •HIV positive serology
- •Lactation, pregnancy
- •Refusing contraception method during treatment period plus 3 months
- •Any medical condition(s) that upon judgment of physician may affect the safety of the patient when treated with study drugs
- •Any concomitant drug that is nephrotoxic
研究组 & 干预措施
1
Liposomal amphotericin B administered intravenously as single dose on day 1, Dosage: 5 mg/kg.
Miltefosine administered orally (50 mg capsules) for 14 days (on days 2-15)
干预措施: Liposomal amphotericin B and Miltefosine (Drug)
结局指标
主要结局
Final Cure six months after the end of treatment
时间窗: 1 year
次要结局
未报告次要终点