Phase IV Randomized Controlled Clinical Trial to Evaluate the Safety and Efficacy of Low-Dose Pentavalent Antimony Compared to the Standard Dose in Patients With Cutaneous Leishmaniasis Caused by Leishmania (Viannia)Braziliensis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Proportion of clinically cured patients at the third month after treatment
研究概览
简要总结
The purpose of this study is to determine whether low-dose pentavalent antimony is equally effective when compared to the standard-dose regimen in patients with cutaneous leishmaniasis. The study will be done in a field clinic in the state of Bahia, Brazil.
详细描述
The first-choice drug for the treatment of cutaneous leishmaniasis in Brazil is the pentavalent antimonial meglumine antimoniate. The treatment with meglumine antimoniate is toxic and at least some of the more relevant adverse events associated with that drug are dose-dependent. Recently, some research developed in Brazil has shown evidence that lower doses of pentavalent antimony are equally efficacious as compared to the standard-dose regimen. That evidence has been obtained in patients from the State of Rio de Janeiro who were infected by Leishmania (Viannia) braziliensis. The purpose of the study is to evaluate the safety and efficacy of the low-dose pentavalent antimony regimen in patients with cutaneous leishmaniasis infected by Leishmania (Viannia) braziliensis living in a rural area of the State of Bahia, Brazil, where cutaneous leishmaniasis is highly endemic. The usefulness of the study is based on the possibility to reduce the toxicity observed during treatment and the treatment costs.
The main comparison of the therapeutic response is going to be made between two groups composed of an equal number of properly randomized patients with localized cutaneous leishmaniasis treated with any of the following drug schemes:
- Meglumine antimoniate (calculated dose based on the concentration of pentavalent antimony) 5 mg/kg/d intravenous for 20 days
- Meglumine antimoniate (calculated dose based on the concentration of pentavalent antimony) 15 mg/kg/d intravenous for 20 days
The clinical outcomes of cure or failure will be evaluated until the third month of follow-up.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Presence of 1 to 9 cutaneous lesions clinically compatible with leishmaniasis
- •Disease duration of 2 to 20 weeks
- •Positive leishmanin skin test
- •Parasitological diagnosis confirmed through culture or genus-specific polymerase chain reaction (PCR) for Leishmania spp
排除标准
- •History of past episode of leishmaniasis
- •Mucosal disease
- •Disseminated disease
- •Use of drugs with anti-leishmanial activity
- •Contraindications for using pentavalent antimony:
- •pregnancy
- •renal failure
- •heart failure
- •hepatic failure
- •Other diseases:
- •active tuberculosis
- •hanseniasis
研究组 & 干预措施
Low dose
Meglumine antimoniate 5 mg/kg/d for 20 days
干预措施: Meglumine antimoniate (Drug)
Standard dose
Meglumine antimoniate 15 mg/kg/d for 20 days
干预措施: Meglumine antimoniate (Drug)
结局指标
主要结局
Proportion of clinically cured patients at the third month after treatment
时间窗: Three months after treatment
Proportion of patients with epithelialized lesions
时间窗: Three months after treatment
次要结局
- Proportion of patients with adherence to the protocol prescribed drug(30 days)
- Proportion of patients with adverse events(30 days after treatment)
- Proportion of patients with late failure after the first three months of follow-up(12 months)