Randomized Clinical Trial of the Efficacy and Tolerability of Oral Miltefosine Versus Parenteral Antimony for the Treatment of Pediatric Cutaneous Leishmaniasis in Colombia
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 150
- 主要终点
- The primary outcome measure will be the proportion of "Therapeutic Failures" diagnosed during the final (week 26) visit or before, according to defined clinical criteria.
研究概览
简要总结
The purpose of this randomized, open label clinical trial is to determine if oral miltefosine is a safe and effective alternative, compared with parenteral meglumine antimoniate for the treatment of pediatric Cutaneous caused by L. Viannia species in Colombia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •2 to 12 years of age (inclusive)
- •Parasitologically confirmed CL
- •Availability to receive supervised treatment for 28 days (i.e., directly observed therapy, to ensure the therapy is appropriately administered and received - e.g., the miltefosine is "swallowed")
- •Availability to return for follow-up visits for at least 6 months after treatment is initiated
排除标准
- •Weight under 10kg
- •Previous use of SbV, miltefosine or other antileishmanial therapy
- •Simultaneous mucosal lesions suggestive of or proven to be mucosal leishmaniasis
- •If a girl, ability to reproduce (history of menarche)
- •Relative or absolute contraindications for the use of SbV drugs or miltefosine, including history of cardiac, renal or hepatic disease
- •Patients with pretreatment haemoglobin <10g/dl or blood urea nitrogen (BUN), serum creatinine, ALT, AST or amylase values that exceed the upper limit of normal
- •If living in Malaria endemic areas (eg. Tumaco) only: A positive malaria thick smear
研究组 & 干预措施
Group 1
Oral administration of Miltefosine, doses: 1,5mg to 2,5mg/kg/day, during 28 days.
presentation: capsulas 10mg and 50mg Miltefosine (Impavido®)
干预措施: Miltefosine (Drug)
Group 2
Administration of Parenteral meglumine antimoniate, Glucantime® Amp 5ml (83mg/ml). Dosage:20mg/kg/day, during 20 days.
干预措施: Meglumine antimoniate (Drug)
结局指标
主要结局
The primary outcome measure will be the proportion of "Therapeutic Failures" diagnosed during the final (week 26) visit or before, according to defined clinical criteria.
时间窗: 26 weeks (6 months)
Evidence of clinical or laboratory toxicity during the treatment period.
时间窗: During the treatment period (20 or 28 days)
次要结局
- Proportion of patients with "parasitologic" response 26 weeks after the initiation of treatment.(26 weeks)