NCT00489658终止2 期
Efficacy and Safety of an Eflornithine + Nifurtimox Combination for Treatment of Late-Stage Human African Trypanosomiasis (HAT) in West Nile, Uganda
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Epicentre
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Treatment failure (death within 30 days of inclusion, or later if judged as related to Human African trypanosomiasis; termination of treatment due to adverse events; evidence of infection relapse at or after discharge, up to 24 months post discharge)
研究概览
简要总结
This case series study follows on a terminated randomised clinical trial in a nearby location of Uganda, in which the combination of eflornithine + nifurtimox showed very promising efficacy and safety. The study's purpose is to evaluate the efficacy and safety of this combination in a larger group of late-stage Human African trypanosomiasis (sleeping sickness) patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stage 2 infection with Trypanosoma brucei gambiense diagnosed within the previous 14 days, as defined by either of the following: (i) Presence of trypanosomes in blood or lymph node fluid and WBC count in CSF > 5 / mm3, or (ii) Presence of trypanosomes in the CSF with any CSF WBC count
- •Residence in the study area
- •Written informed consent (to be obtained from parent/guardian for children under 18 years and patients with impaired cognition)
排除标准
- •Pregnancy or clinical history suggestive thereof
- •Weight < 10 Kg
- •History of any HAT treatment within the previous 24 months
- •Inability to undergo hospitalisation or attend follow-up visits during the 24 months following discharge
- •Severe anemia (Hb< 5g/dl)
- •Active tuberculosis (sputum positive)
- •HIV positive (if patient has been tested and results are known)
- •Severe renal or hepatic failure
- •Bacterial or cryptococcal meningitis
- •Other severe underlying diseases upon admission
- •Refugee status
结局指标
主要结局
Treatment failure (death within 30 days of inclusion, or later if judged as related to Human African trypanosomiasis; termination of treatment due to adverse events; evidence of infection relapse at or after discharge, up to 24 months post discharge)
时间窗: 24 months
次要结局
- Occurrence and severity of serious clinically apparent adverse events(treatment period and up to one month post discharge)
- Occurrence and severity of biochemical (ALAT, creatinine, bilirubin) and haematological (abnormal total and differential leukocyte count, haemoglobin) adverse events(treatment period)
研究者
研究点 (1)
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