Reduced Doses of Antimony Plus Recombinant Human GM-CSF Compared With Antimony in Standard Doses for Cutaneous Leishmaniasis: a Randomized, Single-blind, Placebo-controlled, Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Cure rate or complete cicatrization of the ulcer
研究概览
简要总结
The present study was designed as a randomized, single blind, placebo-controlled, study to evaluate the effect of 400 µg of recombinant human GM-CSF applied intralesionally and associated with half of the total dose of antimony in a reduced time schedule (20mgSbV/Kg/d for 10 days) as compared to the full dose of antimony (20mgSbV/Kg/d for 20 days) to treat cutaneous leishmaniasis ulcers.
详细描述
This is a randomized, single blind placebo-controlled study in which the groups were selected from the cases presenting to the health post. The inclusion criteria were: age between 15 and 50 years, of either sex, diagnosis of cutaneous leishmaniasis of less than 60 days. The diagnostic criteria were the presence of a typical single cutaneous ulcer, localized on lower limbs, and a positive delayed type hypersensitivity test (DTH or Montenegro skin test) to Leishmania antigen.
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
- Single (Investigator)
入排标准
- 年龄范围
- 15 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 15 and 50 years
- •Either gender
- •Diagnosis of cutaneous leishmaniasis
- •Less than 60 days of disease
排除标准
- •Any history of prior anti-leishmania therapy
- •Negative parasitology (aspirate/smear)or negative Montenegro test
- •Pregnancy
- •Age below 15 and above 50 years
- •Other associated acute or chronic illnesses
- •History of allergy to GM-CSF and/or antimony
- •HIV, HTLV-1 infections or diabetes
- •Administrative reasons:
- •Lack of ability or willingness to give informed consent (patient and/or parent / legal representative)
- •Anticipated non-availability for study visits/procedures
研究组 & 干预措施
Group 1
Group 1: Cutaneous leishmaniasis patients randomized in Corte to receive antimony (20mg/daily for 10 days) plus GM-CSF Treatment: antimony (20mg/daily for 10 days) plus GM-CSF (400 µg, divided in two doses a week apart)
干预措施: GMCSF plus Antimony reduced dose (Drug)
Group 2
Group 2: antimony in standard dose plus saline administered in an identical fashion to the GM-CSF.
干预措施: Meglumine antimoniate (Drug)
结局指标
主要结局
Cure rate or complete cicatrization of the ulcer
时间窗: 3 months after treatment
次要结局
- Initial cure rate or complete cicatrization of the ulcer.(2 months after treatment.)