Empiric Antihelminthic Therapy Combined With Antimony in the Treatment of Cutaneous Leishmaniasis: A Randomized Controlled Trial in Subjects Co-Infected With Helminths and Leishmania Brasiliensis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Bidirectional measurements will be taken of the subjects' lesions at each visit and will be categorized as active or healed by a dermatologist.
研究概览
简要总结
The purpose of this project is to investigate the efficacy of early, empiric anti-helminthic therapy combined with standard pentavalent antimony in the treatment of subjects co-infected with helminths and cutaneous leishmaniasis caused by L. brasiliensis. The study hypothesis is that early intervention with antihelminthic therapy will improve response rates to antimony in subjects with cutaneous leishmaniasis.
详细描述
Leishmaniases are a group of diseases caused by a parasite and transmitted by the sand fly. There are a number of diseases associated with infection ranging from simple skin lesions to a severe, fatal form. The standard treatment of cutaneous leishmaniasis (CL) is a 20 day course of antimony which, although fairly effective, has multiple side effects and is difficult to administer. The populations that are affected by leishmaniasis are usually also affected by intestinal helminths (worms). It is unknown what effect these two diseases have on each other and the immune system. As pathology in CL is mediated by an inflammatory reaction and helminths down regulate inflammation, helminthic infection may be beneficial for leishmaniasis. However, a recent study by our research group suggested that subjects infected with both leishmania and helminths have longer healing times and are less likely to respond to antimony. Since failure of initial therapy often results in repeat courses of the drug or development of more severe disease, we propose a study to investigate the role of early treatment for co-existing helminth infections in improving response rates to antimony in subjects with CL.
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
- Double
入排标准
- 年龄范围
- 13 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with a diagnosis of CL based on the presence of typical skin lesions and a positive Montenegro skin test
- •Evidence of helminthic infection by parasitological examination of first stool sample
- •Males or females between 13 and 50 years of age
- •Maximum of 3 ulcers with no more than 2 body regions involved
- •Period of 15 to 60 days from the onset of the first ulcer
- •Subject agreement to follow-up visits and therapy
- •Ability to give informed consent
排除标准
- •Pregnancy
- •Breastfeeding mothers
- •Presence of mucosal disease
- •History of prior treatment with antimonial drugs.
- •History of prior treatment with anthelminthic drugs within the last 6 months.
- •History of allergy to pentavalent antimony or antihelminthic
- •Presence of underlying disease which affects the immune response, such as HIV and diabetes mellitus
结局指标
主要结局
Bidirectional measurements will be taken of the subjects' lesions at each visit and will be categorized as active or healed by a dermatologist.
时间窗: 90 days
次要结局
未报告次要终点