Clinical Trial to Assess Efficacy and Safety of Orally Administered Miltefosine in Brazilian Patients With Cutaneous Leishmaniasis Compared to the Standard Care as Active Control
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Cure rate or complete cicatrization of the ulcer.
研究概览
简要总结
The hypothesis of this trial is that the therapeutic activity and safety of oral miltefosine in Brazilian patients with cutaneous leishmaniasis is similar or superior to the intravenous standard treatment (meglumine antimoniate - Glucantime®).
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
- 2 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed (untreated) cutaneous leishmaniasis with localized lesions and visualization of amastigotes in tissue samples or a positive culture or diagnosed by polymerase chain reaction (PCR) methods or by intradermal skin testing (Montenegro test).
- •Number of lesions: 1 to 5 ulcerative lesions.
- •Lesion´s diameter: 1 to 5 cm.
- •Disease duration: up to three months.
排除标准
- •Safety concerns:
- •Thrombocyte count <30 x 109/l
- •Leukocyte count <1 x 109/l
- •Hemoglobin <5 g/100 ml
- •ASAT, ALAT, AP >3 times upper limit of normal range
- •Bilirubin >2 times upper limit of normal range
- •Serum creatinine or BUN >1.5 times upper limit of normal range
- •Evidence of serious underlying disease (cardiac, renal, hepatic or pulmonary)
- •Immunodeficiency or antibody to HIV
- •Any non-compensated or uncontrolled condition, such as active tuberculosis, malignant disease, severe malaria, HIV, or other major infectious diseases
- •Lactation, pregnancy (to be determined by adequate test) or inadequate contraception in females of childbearing potential for treatment period plus 2 months
- •Lack of suitability for the trial:
- •Negative parasitology (aspirate/smear)or negative Montenegro test
- •Any history of prior anti-leishmania therapy
- •Any condition which compromises ability to comply with the study procedures
- •Concomitant serious infection other than cutaneous
- •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
1.1
Cutaneous leishmaniasis patients in Manaus-Amazonas randomized to receive Miltefosine.
干预措施: Miltefosine. (Drug)
1.2
Cutaneous leishmaniasis patients in Manaus-Amazonas randomized to receive Meglumine antimoniate (standard treatment).
干预措施: Meglumine antimoniate. (Drug)
2.1
Cutaneous leishmaniasis patients in Corte de Pedra-Bahia randomized to receive Miltefosine.
干预措施: Miltefosine. (Drug)
2.2
Cutaneous leishmaniasis patients in Corte de Pedra-Bahia randomized to receive Meglumine antimoniate (standard treatment).
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: 6 months after treatment.
Bidirectional measurements of ulcers will be taken of the patients' lesions at the initial visit, and at each follow-up visit with standardized caliper. The area involved will be calculated as the product of the two measurements. All lesions will be categorized as either active or healed (cured) at follow-up visits. Only lesions with complete re-epithelialization, without raised borders, infiltrations or crusts will be considered healed. Evaluation of the lesions will be performed by 2 clinicians who will be unaware of the group assignment of all patients.
次要结局
- Inicial cure rate or complete cicatrization of the ulcer.(2 months after treatment.)