Combination chemotherapy against visceral leishmaniasis: Comparative evaluation between miltefosine for 4 weeks and 2 weeks miltefosine combined with single dose liposomal amphotericin B in a tertiary care centre in Kolkata
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 2. Parasitological : Spleen/ Bone marrow smear
研究概览
简要总结
India is burdened with approximately 50,000 annual cases of Kala azar/visceral leismaniasis (VL). Visceralleishmaniasis remains invariably fatal untreated. With widespreadresistance to pentavalent antimony, the conventional first line drug, oral miltefosine and injectable amphotericin B has become standard of care. Miltefosine is resistance prone when used singly and amphotericn B is potentially toxic and requires prolonged regimens of infusions. Recently the liposomal preparation of amphotericin B hasimproved management outcome through lower toxicity and shorter duration oftherapy. In this proposed study we would like to compare the two regimens namely miltefosine monotherpay for 4 weeks which is standard NVBDCP recommendation in India and combination chemotherapy with single dose liposomal amphotericn B followed by miltefosine for 2 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Open Label
入排标准
- 年龄范围
- 5.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with corroborative clinical history (prolonged fever not responding to antimalarials or antibiotics) and physical signs (anaemia, splenomegaly, hepatomegaly) with presence of parasites (LD bodies) confirmed by examination of Giemsa stained slides of splenic or bone marrow aspirates were enrolled into the study.
- •Confirmed visceral leishmaniasis patients who are fully informed about the risk of treatment and who signed the consent form themselves or by authorised relatives in their languages , will be included in the study group.
排除标准
- •HIV positive individuals, Infant and children with body weight < 10Kgs, severe concurrent illnesses, receipt of any antileishmanial drugs or antifungal drugs in the previous 45 days, pregnancy and withdrawal of contraceptive measure.
- •Patients with known hypersensitivity to the study drugs and those with diabetes, hypertension, or tuberculosis were also excluded.
- •All patients with known heart, liver or kidney disease were excluded from the study.
- •patients with renal function tests (serum creatinine) outside the normal range, liver function tests (transaminases) more than three times upper limit of the normal at study entry, Jaundice (bilirubin > 2.0mg/dL), Known hepatitis B or C positive, Platelet count less than 40,000/mm3, Prothrombin time 5 seconds or greater than normal range, Total WBC < 1,000/mm3, known alcohol or other drug abuse,concomitant chronic drug treatment eg for diabetes, hypertension, TB, HIV etc, concomitant drug usage for acute infection, eg malaria, pneumonia etc within the last 7 days were excluded.
结局指标
主要结局
2. Parasitological : Spleen/ Bone marrow smear
时间窗: 1. Clinical : end of treatment, at 6 months of follow - up and 2 - 4 years of follow up | 2. Parasitological: End of treatment, at 6 months
1. Clinical : fever , Spleen size, Anaemia, appetite, Body weight
时间窗: 1. Clinical : end of treatment, at 6 months of follow - up and 2 - 4 years of follow up | 2. Parasitological: End of treatment, at 6 months
次要结局
- Drug related adverse effects (Common Terminology Criteria for Adverse Events version 3.0)(Throughout treatement duration and at six months)