NCT00906880已完成4 期
Clinical Study to Assess the Clinical Tolerability, Feasibility and Effectiveness Under Field Conditions of the Combination of Nifurtimox and Eflornithine (NECT) for the Treatment of T.b.Gambiense Human African Trypanosomiasis (HAT) in the Meningo-encephalitic Stage
Drugs for Neglected Diseases12 个研究点 分布在 2 个国家目标入组 630 人开始时间: 2009年4月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 630
- 试验地点
- 12
- 主要终点
- Proportion of patients discharged alive from the hospital or the treatment center
研究概览
简要总结
Multicenter, open label, uncontrolled phase IIIb study of therapeutic use of the combination of nifurtimox and eflornithine (NECT) for the treatment of Trypanosoma brucei gambiense human African trypanosomiasis (HAT) in the meningo-encephalitic phase.
Overall objectives:
Assess the clinical tolerability, feasibility and effectiveness of NECT co-administration to treat patients with T.b. gambiense human African trypanosomiasis (HAT) in the meningo-encephalitic phase in actual real-life conditions (regular treatment centers of the National HAT Control Programme, NGO treatment centers).
Primary objective:
- Assess the clinical response of the NECT co-administration under field conditions.
Secondary objectives:
- Assess the incidence and type of adverse events (AE), and the capacity of the treatment centers to deal with these.
- Assess the feasibility of the implementation of the NECT coadministration by the health center.
- Assess the effectiveness of the NECT co-administration at 24* months after treatment.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients diagnosed as stage 2 HAT according to the diagnostic protocols in use at the treatment center (generally, if presence of parasites in blood, lymph node fluid or CSF and an elevated white blood cell count in the CSF, but this can vary from center to center) will be included if a written Informed Consent is given by the patient or a legally acceptable representative if the patient is a minor or unable to communicate.
- •Pregnancy and breastfeeding women: On a case by case basis according to the guidelines of the National HAT Control Programme or the NGO, the Investigator will decide to treat the patient or to defer the treatment. In case of inclusion, the mother-child pairs or the children of lactating mothers will be closely monitored during treatment and follow up.
- •Children under 2 years of age: On a case by case basis, the Investigator will decide to treat an infant with NECT or an alternative treatment (preferably eflornithine). In case of inclusion, these infants will be closely monitored during treatment and follow up like all children less than 12 years of age.
排除标准
- •Unable to take oral medication, and impossibility to use a nasogastric tube.
- •Treatment failure after nifurtimox-eflornithine treatment.
- •Any other condition or reason for which the Investigator (or the responsible treating staff member) judges that another or no HAT treatment is warranted.
结局指标
主要结局
Proportion of patients discharged alive from the hospital or the treatment center
次要结局
- Incidence of serious AE (SAE) and severe AE (CTC score 3 and 4) related to treatment, and overall frequency and nature of AE and need for additional medications to manage these.(up to 24 months after treatment)
- Effectiveness: The clinical cure rate (Survival without clinical and/or parasitological signs of HAT)(24 months after treatment)
- Number of temporary treatment interruptions, number of premature treatment cessations, length of hospitalization stay (including observation period), treatment compliance (deviation in dosing), and other feasibility indicators.(during the treatment/hospitalisation time)
研究者
研究点 (12)
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