A Phase II Randomized, Parallel Arm, Open-labeled Clinical Trial to Assess the Safety and Efficacy of the Combination of Sodium Stibogluconate Plus Single Dose AmBisome®, Miltefosine Plus Single Dose AmBisome® and Miltefosine Alone for the Treatment of Primary Visceral Leishmaniasis in Eastern Africa
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 151
- 试验地点
- 3
- 主要终点
- Initial cure: proportion cured at Day 28
研究概览
简要总结
This study is to assess if shorter combinations of SSG plus single dose AmBisome®, Miltefosine plus single dose AmBisome® and Miltefosine alone are effective in treating visceral leishmaniasis in Eastern Africa.
详细描述
The current study intends to look at potential feasible short course combination therapies as well as evaluate (and possibly register) miltefosine in its conventional dose against VL in Sudan and Kenya.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with clinical signs and symptoms of VL and diagnosis confirmed by visualization of parasites in tissue samples (lymph node, bone marrow or spleen where relevant) on microscopy.
- •Patients aged between 7 (to allow for blood sampling) and 60 years (inclusive) who are able to comply with the protocol.
- •Patients for whom written informed consent has been signed by the patients themselves (if aged 18 years and over) or by parents(s) or legal guardian for patients under 18 years of age.
- •HIV negative status
排除标准
- •Patients who have received any anti-leishmanial drugs in the last 6 months/ relapse cases.
- •Patients with a negative lymph node/bone marrow (or spleen) smears.
- •Patients with severe protein and or caloric malnutrition (Kwashiorkor or marasmus ; Adults: BMI </= 15, Children W/H<70, presence of oedema)
- •Patients with previous history of hypersensitivity reaction to SSG or Amphotericin B.
- •Patients suffering from a concomitant severe infection such as TB or any other serious underlying disease (cardiac, renal, hepatic) which would preclude evaluation of the patient's response to study medication.
- •Patients suffering from other conditions associated with splenomegaly such as schistosomiasis.
- •Patients with previous history of cardiac arrhythmia or an abnormal ECG
- •Patients who are female of child bearing age (all females who have achieved menarche) / pregnant or lactating.
- •Patients with haemoglobin < 5gm/dl.
- •Patients with WBC < 1 x 10³/mm³.
- •Patients with platelets < 40,000/mm³.
- •Patients with abnormal liver function (ALT and AST) tests of more than three times the normal range.
- •Patients with serum creatinine outside the normal range for age and gender.
- •Major surgical intervention within 2 weeks prior to enrolment.
研究组 & 干预措施
Amb+SSG
AmBisome® one dose of 10mg/kg body weight (IV) on day 1 followed by 10 days of SSG at 20mg/kg body weight (IV/IM) from days 2-11
干预措施: Liposomal amphotericin B (AmBisome®) and sodium stibogluconate (Drug)
Amb+Milt
AmBisome® one dose of 10mg/kg body weight (IV) on day 1 followed by 10 days Miltefosine at 2.5mg/kg body weight (oral) from days 2-11
干预措施: Liposomal amphotericin B + miltefosine (Drug)
Milt
Monotherapy course of Miltefosine at 2.5mg/kg body weight (oral) from days 1-28
干预措施: Miltefosine (Drug)
结局指标
主要结局
Initial cure: proportion cured at Day 28
时间窗: Day 28
次要结局
- Adverse events and serious adverse events occurring in the three study arms(up to day 60)
- Final cure: proportion cured at day 210(6 months post treatment)