Clinical Trial Comparing the Therapeutic Combinations Melarsoprol-Nifurtimox, Melarsoprol-Eflornithine and Eflornithine-Nifurtimox in the Treatment of Gambiense Human African Trypanosomiasis in the Meningo-Encephalitic Phase
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Epicentre
- 入组人数
- 435
- 试验地点
- 1
- 主要终点
- Cure rate
研究概览
简要总结
The treatment human African trypanosomiasis (HAT) in the meningoencephalitic phase relies on two molecules officially registered: melarsoprol, the most commonly used, has a poor safety profile and is becoming ineffective due to parasite resistance; and eflornithine, with better tolerance but more complicated and expensive to implement in endemic countries. nifurtimox, registered only for Chagas' disease but used off-label since the 1970's in series of cases of HAT, is at present the only other available alternative.
The very limited number of compounds available, the lack of prospects for the development of new products and the emergence of resistance are arguments for the use of therapeutic combinations.
This study evaluates the efficacy and safety of three drug combination therapies: melarsoprol-nifurtimox, melarsoprol-eflornithine and eflornithine-nifurtimox.
详细描述
Dosages per drug are the same in either arm of the study: IV melarsoprol 1.8 mg/kg/day, daily for 10 days; IV eflornithine 400 mg/kg/day, 6-hourly for 7 days; oral nifurtimox 15 or 20 (children <15 years) mg/kg/day, 8-hourly for 10 days.
For efficacy assessment, patients are followed-up for 24 months after treatment, with planned clinical and laboratory controls.
The safety assessment includes clinical and hematological adverse events.
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
- 0 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •confirmed second-stage T.b. gambiense infection :
- •Infection diagnosed parasitologically (blood or lymph node fluid) and white blood cells > 5/mm3 in cerebrospinal fluid (CSF)
- •or Trypanosomes detected in the CSF with any CSF cell count
- •and resident in the district
- •and written consent of the patient or of one of the parents/guardians for children under 15 years of age.
排除标准
- •Trypanosome absent from blood (or lymph node fluid) and from CSF
- •Or women pregnant on inclusion
- •Or previous history of HAT confirmed treated during the last 24 months
- •Or impossibility of regular access to the treatment centre during the 2 years following the end of the treatment
- •Or less than 10 kg of body weight
- •Or refugee patient
结局指标
主要结局
Cure rate
次要结局
- Adverse events temporally associated with the treatment
- Major adverse events temporally associated with the treatment