NCT06040489招募中2 期
Pilot Study: Oral Treatment of American Tegumentary Leishmaniasis (Cutaneous and Mucosal Forms) in the Elderly
University of Brasilia1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年6月22日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Cure
研究概览
简要总结
Randomised clinical trial comparing oral miltefosine associated with pentoxifylline to intravenous liposomal amphotericin b for the treatment of cutaneous and mucosal leishmaniasis
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Active confirmed cutaneous leishmaniasis ou mucosal leishmaniasis
- •Use of highly effective contraceptive method and a negative serologic pregnancy test (beta - HCG), if female in fertile phase
- •Agree and sing informed consent form
排除标准
- •Previous treatment with leishmanicidal drugs in the last 6 months
- •Pre-treatment electrocardiographic changes that contraindicate the use of liposomal amphotericin B (QTc greater than 450ms)
- •Serum creatinine or urea 1.5 times the upper limit of normal
- •Patients with severe or decompensated liver, kidney, heart disease, Diabetes Mellitus
- •history of any hypersensitivity reaction to liposomal amphotericin B, miltefosine and/or pentoxifylline
- •Pregnant and breastfeeding women
- •Patients with Acquired Immunodeficiency Syndrome (AIDS) or other immunodeficiency
研究组 & 干预措施
Oral Miltefosine and Pentoxifylline for Cutaneous Leishmaniasis
Experimental
干预措施: Miltefosine 50mg (Drug)
Oral Miltefosine and Pentoxifylline for Cutaneous Leishmaniasis
Experimental
干预措施: Pentoxifylline 400mg (Drug)
Oral Miltefosine and Pentoxifylline for Mucous Leishmaniasis
Experimental
干预措施: Miltefosine 50mg (Drug)
Oral Miltefosine and Pentoxifylline for Mucous Leishmaniasis
Experimental
干预措施: Pentoxifylline 400mg (Drug)
Intravenous Liposomal Amphotericin B for Cutaneous Leishmaniasis
Active Comparator
干预措施: Liposomal Amphotericin B (Drug)
Intravenous Liposomal Amphotericin B for Mucous Leishmaniasis
Active Comparator
干预措施: Liposomal Amphotericin B (Drug)
结局指标
主要结局
Cure
时间窗: 90 days after the begin of treatment
Complete healing of all lesions (cicatrization of ulcers and complete regression of erythema or infiltration)
次要结局
- Adverse effects(30 days after drug interruption)
研究者
研究点 (1)
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