Comparative efficacy and safety of Rifampicin, Minocycline and Clarithromycin monthly pulse regimen versus standard WHO multidrug regimen in leprosy A randomized controlled study
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To prove RCM regimen comprising of monthly once supervised dose of Rifampicin 600mg ,Clarithromycin 500mg and Minocycline 200mg (RCM) in treatment of pauci and multi bacillary hansen is equally efficacious as WHO MDT in treatment of leprosy
研究概览
简要总结
Leprosy, caused by Mycobacterium leprae is a debilitating disease of skin and peripheral nerves.
•Multidrug therapy comprising of Rifampicin, Clofazimine and Dapsone is the standard regimen in the treatment of leprosy
•Although effective, MDT has various side effects ranging from dapsone hypersensitivity syndrome which can be lethal to clofazimine induced pigmentation that can be cosmetically unappealing and may take months to resolve.
•The higher pill burden also contributes to a decreased compliance
•Although WHO MDT has significantly reduced the prevalence of disease burden , the associated adverse effects have impacted adherence, thus affecting overall treatment outcome.
Hence there is a need to consider alternative regimens with a higher safety profile to improve treatment efficacy and adherence.
Thus, we are introducing a regimen comprising of three bactericidal drugs Rifampicin, Clarithromycin and Minocycline (RCM) administered monthly once under supervision in treatment of newly diagnosed cases of Leprosy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •All new cases fulfilling cardinal signs of leprosy and biopsy proven patients above 18 years of age.
排除标准
- •Patients on steroids and other immunosuppressive drugs Pregnancy and lactation Pure neuritic leprosy Contraindications to the drugs in regimen.
结局指标
主要结局
To prove RCM regimen comprising of monthly once supervised dose of Rifampicin 600mg ,Clarithromycin 500mg and Minocycline 200mg (RCM) in treatment of pauci and multi bacillary hansen is equally efficacious as WHO MDT in treatment of leprosy
时间窗: patients are assessed at baseline , at 6 months and 12 months of therapy
次要结局
- To prove RCM regimen comprising of monthly once supervised dose of Rifampicin 600mg ,Clarithromycin 500mg & Minocycline 200mg (RCM) in treatment of pauci & multi bacillary hansen has more safety profile with less side effects when compared to daily WHO MDT in treatment of leprosy(patients are assessed at baseline , 6 months & 12 months of treatment)
研究者
Dr Minu s kani
Kalinga institute of medical sciences