Does additional clofazimine for MB cases at high risk of ENL improve their prognosis/outcome over 2 years?
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- 1.Compared within BL/LL subjects who have or previously had at least 1 episode of ENL before RFT or within 12m of RFT after fixed duration MDT of 12m,
研究概览
简要总结
Using un-blinded randomised controlled trial in 2 predominantly-urban community situations (one in India, one in Bangladesh) (using the ENLIST ENL severity scale & the SF36 tool for health-related quality of life for objective outcome measures), we will address the question:
1) 1) Does 6-12m additional clofazimine given to patients who have had at least one episode of ENL, reduce the frequency and severity of ENL over 24 months period? (“additional clofazimine†means daily dose of 300mg for 8 weeks, then 200mg for 8 weeks, then 100mg for 8 -32 weeks according to tolerance)
2) 2) The control group will receive similar-looking capsules of vitamins Placebo (it is impossible to fully blind the trials on account of the skin discoloration associated with high dose of clofazimine**).**
Primary Objective:
1. 1) Compared within BL/LL subjects who have or previously had at least 1 episode of ENL before RFT or within 12m of RFT after fixed duration MDT of 12m,
2. 2) To compare the proportion who have recurrence and severity and of ENL over 24 months observation, in those who receive additional clofazimine (at least 100mg/day for 6-12m) with that in those who receive only clofazimine at 50mg /day (or none if RFT).
Secondary Objective:
1.To compare proportion with increased nerve function impairment in same two groups.
- To compare the change in health-related quality of life in same two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Smear positives cases, i.e. smear positive at diagnosis within 24 months of starting Multibacillary Multidrug Therapy (MBMDT)(as new case, returned defaulter or relapse), i.e. on 12 m fixed duration MBMDT or within 12m of completion of 12m Fixed Duration (FDMBMDT) or on 24m FDMBMDT.
- •People who have or previously had ENL, ENL as defined in ENLIST publications, at any time in past, confirmed by Doctor (physical exam or clinic records), or currently.
- •1st episode of ENL or recurrent episode (after interval without treatment of>27 days), i.e. exclude chronic ENL (symptoms of ENL and /or treatment for ENL for 24 weeks or more without any interval of >27days) 4) over 18 years old up to 60 years 5)minimum weight 40 kg or BMI>18.5.
排除标准
- •Type 1 reaction, i.e. currently (may occur in BB, BL cases) A past history of type one reaction already fully treated and resolved would not exclude case.
- •Cannot understand about study or lives too far away to attend regularly for follow up, i.e. unable to give truly informed voluntary consent or to cooperate with all assessments 3) Chronic bowel disorder, (e.g. chronic amebic dysentery, ulcerative colitis, irritable bowel syndrome, suspected intestinal TB, malabsorption syndrome etc).
- •Other serious illness likely to interfere with safety or compliance, e.g. HIV, chronic moderate/severe renal impairment, Tb, cancer, uncontrolled type 1 diabetes.
- •Serious adverse effects of steroids in past such as standard regimen in field would not be safe (e.g. GI haemorrhage, glaucoma, steroid-induced psychosis).
结局指标
主要结局
1.Compared within BL/LL subjects who have or previously had at least 1 episode of ENL before RFT or within 12m of RFT after fixed duration MDT of 12m,
时间窗: 12,24,36,48 months
2.to compare the proportion who have recurrence and severity and of ENL over 24 months observation, in those who receive additional clofazimine (at least 100mg/day for 6-12m) with that in those who receive only clofazimine at 50mg /day (or none if RFT).
时间窗: 12,24,36,48 months
次要结局
- 1. To compare proportion with increased nerve function impairment in same two groups.(2. To compare the change in health-related quality of life in same two groups.)