Low-dose Pentavalent Antimony Treatment of Cutaneous Leishmaniasis in Old Age Patients Infected With Leishmania (Viannia) Braziliensis in Bahia State, Brazil. An Open Uncontrolled Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Clinical cure
研究概览
简要总结
This study was designed to evaluate the effect of low doses of pentavalent antimony (meglumine antimoniate) to treat cutaneous leishmaniasis ulcers in patients older than 65 years. The hypothesis is that older patients may have a positive response with a lower dose of pentavalent antimony, avoiding the frequent adverse events observed with the standard dose. The design is that of an open uncontrolled trial enrolling 20 patients infected with the parasite Leishmania braziliensis in an endemic area of the State of Bahia, Brazil. The endpoint of cure or therapeutic failure will be evaluated at the third month of follow-up after treatment to avoid the impact of spontaneous cure as a confounding factor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 65 years
- •Permanent residence in the endemic area
- •Availability of a caregiver for dependent patients
排除标准
- •Mucosal disease caused by leishmaniasis
- •Disseminated cutaneous disease
- •Severe cardiac, renal or hepatic disorders
- •Active cancer
- •Active tuberculosis
- •HIV positive
- •Total bilirubin > 1.5mg/dL
- •Urea and creatinin > 1.5 times the upper normal level
- •Alkaline phosphatase and aminotransferases > 2.5 times the upper normal level
- •Lipase and amylase > 1.5 the upper normal level
- •Hemoglobin < 5 g/dL of
研究组 & 干预措施
Meglumine antimoniate
Treated with 5mg/kg/d of pentavalent antimony (meglumine antimoniate) intravenously for 20 consecutive days.
干预措施: Meglumine antimoniate (Drug)
结局指标
主要结局
Clinical cure
时间窗: Three months after treatment
Clinical cure defined as the complete epithelialization of the ulcerated lesions without any inflamatory sign (erythema, edema, disquamation)
次要结局
- Adverse events rate - day 7(7th day)
- Adverse events rate - day 14(14th day)
- Total Adverse events rate(20th day)