Point of Care Diagnosis and Treatment With Single Dose Liposomal Amphotericin B for Visceral Leishmaniasis in India.
试验速览
- 阶段
- 4 期
- 入组人数
- 1,300
- 试验地点
- 1
- 主要终点
- CLINICAL CURE
研究概览
简要总结
The study is designed to determine the use of delivering point of care, rapid diagnosis with rK39 and treatment with AmBisome single dose of 10 mg/kg when administrated in the Primary Health Center (PHC) settings with regard to operational feasibility, safety and final cure rate at 6 months after end of treatment. Point of care diagnosis and treatment (PCDT) at the PHC level would bring the best available interventions closer to the patients with visceral leishmaniasis (VL) whose villages are within several kilometers of the PHC. This would support the VL elimination program in the Indian subcontinent.
详细描述
Primary Objectives:
To evaluate the operational feasibility of delivering point of care, rapid diagnosis with rK39 and treatment with AmBisome® single dose of 10 mg/kg, when administrated at the Primary Health Centers (PHC) setting with regard to feasibility and safety .
Secondary objectives:
To determine efficacy of the treatment scheme when delivered by district hospitals and PHC facilities
Methodology:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients ≥ 5 years of age
- •History of fever for more than 2 weeks
- •Splenomegaly
- •rK 39 rapid test positive
- •Biochemical and hematological test values as follows:
- •Hemoglobin ≥ 5 g/dl
- •White blood cell count ≥1.0 x 109/L
- •AST, ALT ≤ 3 times the upper limit of normal
- •Serum creatinine level within normal limit
- •Written informed consent from the patient/ or parent or guardian if under 18 years old.
排除标准
- •A history of intercurrent or presence of clinical signs / symptoms of concurrent diseases / conditions (e.g. Chronic alcohol consumption or drug addiction, renal, hepatic, cardiovascular or CNS disease; diabetes mellitus, dehydration, other infectious diseases or major psychiatric diseases) only if the intercurrent conditions are not under control before starting the treatment with AmBisome.
- •Any condition which according to the investigator might prevent the patient from completing the study therapy and subsequent follow up
- •A history of allergy or hypersensitivity to Amphotericin B
- •Previous treatment for VL
- •Prior treatment failure with Amphotericin B
- •Post Kala-azar Dermal Leishmaniasis (PKDL
研究组 & 干预措施
SINGLE DOSE AMBISOME
干预措施: AMBISOME (Drug)
结局指标
主要结局
CLINICAL CURE
时间窗: 24 MONTHS
次要结局
未报告次要终点
研究者
Shyam Sundar
PROFESSOR
Banaras Hindu University