The Association of Miltefosine and Pentoxifylline to Treat Mucosal and Cutaneous Leishmaniasis: An Open-label, Randomized Clinical Trial in Brazil
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Cure
研究概览
简要总结
Mucocutaneous leishmaniasis is endemic in the central region of Brazil and other countries worldwide. The standard treatment with meglumine antimoniate has a high rate of important adverse effects. This interventional study consists in a randomized clinical trial to access efficacy and safety of the association of miltefosine and pentoxifylline compared to meglumine antimoniate and pentoxifyline.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mucosal and/or cutaneous leishmaniasis, not treated or at least 6 months without any treatment to leishmaniasis;
- •For patients with cutaneous lesions: duration of disease longer then a 1 month and shorter then 4 yeas; 1 to 3 lesions; larger lesions from 10mm to 50mm;
- •Ages between 18 and 80 years old;
- •Fertile female patients should use at least two contraceptive methods (hormonal and barrier);
- •Agree to participate in the study and sign the informed consent term.
排除标准
- •Use of any leishmanicidal drugs six months prior;
- •Clinical or laboratorial evidences of electrocardiographic disorders;
- •Renal, hepatic, cardiac diseases, uncontrolled diabetes or AIDS;
- •Hypersensitivity to meglucamine antimoniate;
- •Pregnancy or lactation;
- •Fertile females that do not agree to use contraceptive methods;
- •Patients that do not agree to the informed consent term.
研究组 & 干预措施
Group 1 - Mucosal Antimoniate and Pentoxifylline
20mgSb+5/kg/day meglumine antimoniate intravenous for 28 days. Pentoxifylline 400mg 3x/daily for 28 days.
干预措施: Meglumine antimoniate (Drug)
Group 1 - Mucosal Antimoniate and Pentoxifylline
20mgSb+5/kg/day meglumine antimoniate intravenous for 28 days. Pentoxifylline 400mg 3x/daily for 28 days.
干预措施: Pentoxifylline (Drug)
Group 2 - Mucosal Miltefosine and Pentoxifylline
Oral Miltefosine 2,5mg/kg/day up to 50mg 2x/daily. Oral Pentoxifylline 400mg 3x/daily for 28 days.
干预措施: Miltefosine (Drug)
Group 2 - Mucosal Miltefosine and Pentoxifylline
Oral Miltefosine 2,5mg/kg/day up to 50mg 2x/daily. Oral Pentoxifylline 400mg 3x/daily for 28 days.
干预措施: Pentoxifylline (Drug)
Group 3 - Cutaneous Antimoniate and Pentoxifylline
20mgSb+5/kg/day meglumine antimoniate intravenous for 20 days Oral Pentoxifylline 400mg 3x/daily for 20 days.
干预措施: Meglumine antimoniate (Drug)
Group 3 - Cutaneous Antimoniate and Pentoxifylline
20mgSb+5/kg/day meglumine antimoniate intravenous for 20 days Oral Pentoxifylline 400mg 3x/daily for 20 days.
干预措施: Pentoxifylline (Drug)
Group 4 - Cutaneous Miltefosine and Pentoxifylline
Oral Miltefosine 2,5mg/kg/day up to 50mg 2x/daily Oral Pentoxifylline 400mg 3x/daily for 20 days.
干预措施: Miltefosine (Drug)
Group 4 - Cutaneous Miltefosine and Pentoxifylline
Oral Miltefosine 2,5mg/kg/day up to 50mg 2x/daily Oral Pentoxifylline 400mg 3x/daily for 20 days.
干预措施: Pentoxifylline (Drug)
结局指标
主要结局
Cure
时间窗: 90 days
Complete healing of previous lesions until the 90th day after the begin of the treatment
Failure
时间窗: 90 days
Lesions fail to heal until the 90th day after the begin of the treatment
Relapse
时间窗: 90 days
Lesions that reappear on the scar of a previously healed lesion
次要结局
未报告次要终点
研究者
SOFIA SALES MARTINS
MD, PhD
University of Brasilia