Effect of Additional Clofazimine on ENL Reactions in Leprosy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Incidence of ENL reactions
研究概览
简要总结
This study is a double-blind, randomized controlled trial examining the effect on ENL reactions of giving an additional year of clofazimine after completion of MDT in leprosy.
详细描述
Clofazimine is an anti-bacterial agent used to treat leprosy; it is a normal component of WHO-recommended multi-drug therapy (MDT). It is also known to have a beneficial effect in one of the common immunological reactions that occur in leprosy, known as erythema nodosum leprosum, or ENL. When MDT was reduced in length from 24 to 12 months, evidence suggests that ENL became worse. This study is a double-blind, randomized controlled trial examining the effect of giving an additional year of clofazimine after completion of MDT. The endpoints are the incidence and severity of ENL over a period of 3 years in the 2 groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •15 to 70 years of age
- •MB leprosy
- •Pretreatment BI of 4 or more at any site
排除标准
- •Presence of another serious illness
- •Refusal of informed consent
研究组 & 干预措施
Placebo group
These patients will receive placebo for 12 months after completion of MDT.
干预措施: Placebo (Drug)
Clofazimine for 12 months after MDT
Patients will be given clofazimine (100mg daily) for 12 months after completion of MDT.
干预措施: Clofazimine (Drug)
结局指标
主要结局
Incidence of ENL reactions
时间窗: 2 years of follow-up
The hypothesis is that additional clofazimine will reduce the incidence of ENL reactions in the two years following completion of MDT.
次要结局
- Severity of ENL reactions(2 years of follow-up)
研究者
Paul Saunderson
Scientific Director
Leonard Wood Memorial