Study for Evaluation of the Immune Response of Visceral Leishmaniasis Patients Treated With Antimonial Pentavalent Associated to N-Acetylcysteine
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Patient recovery from the visceral leishmaniasis after treatment
研究概览
简要总结
This study is designed to evaluate the immune and therapeutic responses of visceral leishmaniasis patients using N-acetylcysteine (NAC) as an adjuvant therapy to pentavalent antimony.
详细描述
In this study we intend to evaluate the immune and therapeutic responses of patients with visceral leishmaniasis N-acetylcysteine (NAC) as an adjuvant to standard treatment with pentavalent antimony, compared to treatment with antimonial only through a blind randomized clinical trial. Our hypothesis is that patients treated with NAC associated with pentavalent atimonial have a rapid changing of the immune responses, towards TH1, and clinical improvement when compared to patients who will use only the standard treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 2 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 2 to 50 years
- •Diagnosis of visceral leishmaniasis
排除标准
- •Other acute or chronic diseases
- •Use of immunosuppressive drugs
- •History of allergy to NAC and/or pentavalent antimony
研究组 & 干预措施
Group 1
Pentavalent antimonial, 20mg/kg/day, 28 days, IV, plus N-acetylcysteine (NAC), effervescent tablets of 600mg, tid, po.
干预措施: N-acetylcysteine (Drug)
Group 2
Pentavalent antimonial, 20mg/kg/day, 28 days
干预措施: Pentavalent antimonial (Drug)
结局指标
主要结局
Patient recovery from the visceral leishmaniasis after treatment
时间窗: 6 months
The cure is defined in the patient with reduced spleen and liver. Absence of fever for more than 15 days after treatment, weight gain, normalization of globulins and resolution of leukopenia and anemia.
次要结局
- Immune response of visceral leishmaniasis patients after proposed treatment(one year)