Transition-state Analog Inhibitor of Human Purine Nucleoside Phosphorylase as an Adjunct in Cutaneous Leishmaniasis Therapy: a Randomized and Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 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
A clinical trial to asses efficacy and safety of Transition-state Analog Inhibitor of Human Purine Nucleoside Phosphorylase for topical use associated standard antimonial in the treatment of Cutaneous Leishmaniasis in Bahia, Brazil.
详细描述
The treatment of cutaneous leishmaniasis caused by L. braziliensis in Brazil with pentavalent antimony is associated with a high rate of failure, reaching up to 45% of cases. Additionally, pentavalent antimony is only administered by parenteral route with important toxicity and ulcer lesion healing takes a long time, from 2 to 3 months.
So, this randomized and controlled clinical trial was designed to compare the efficacy and safety of standard antimonial (20mg/day /kg for 20 days) associated with Transition-state Analog Inhibitor of Human Purine Nucleoside Phosphorylase for topical use versus standard antimonial (20mg/kg/day for 20 days) associated with placebo for topical use in the treatment of Cutaneous Leishmaniasis and Early Cutaneous Leishmaniasis caused by L. braziliensis in the endemic area of Corte de Pedra, Bahia, Brazil.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed (untreated) cutaneous leishmaniasis or early cutaneous leishmaniasis with localized lesions and a positive culture or diagnosed by polymerase chain reaction (PCR) methods or by intradermal skin testing (Montenegro test).
- •Number of lesions: 1 to 3 ulcerative lesions.
- •Lesion´s diameter: 1 to 5 cm.
- •Disease duration: up to three months.
排除标准
- •Aspartate aminotransferase, alanine aminotransferase >3 times upper limit of normal range
- •Serum creatinine or blood urea nitrogen >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
- •Negative parasitology (aspirate/biopsy/PCR) or negative Montenegro test
- •Any history of prior anti-leishmania therapy
- •Any condition which compromises ability to comply with the study procedures
- •Lack of ability or willingness to give informed consent (patient and/or parent / legal representative)
- •Anticipated non-availability for study visits/procedure
研究组 & 干预措施
Immucillin DI4G
Meglumine Antimoniate by intravenous route at 20mg/kg/day during 20 days + Immucillin DI4G 2% by topical use once a day at the ulcer for 20 days .
干预措施: Immucillin DI4G (Drug)
Meglumine Antimoniate
Meglumine Antimoniate by intravenous route at 20mg/kg/day during 20 days + placebo for topical use once a day at the ulcer for 20 days.
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
- Initial cure rate or complete cicatrization of the ulcer.(2 months after treatment)
研究者
Fernanda V Prates, MD, MSc
Principal Investigator
Hospital Universitário Professor Edgard Santos