CTRI/2010/091/000159招募中未知
"Safety and efficacy of liposomal amphotericin B (Ambisome) in patients with post kala-azar dermal leishmaniasis(PKDL)".
RMRIMS(ICMR).0 个研究点目标入组 50 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •?Male or female patient aged 5 years or older
- •?Post kala azar dermal leishmaniasis (PKDL), parasitologically confirmed (amastigotes in slit-skin or snip skin smears and/or skin biopsies)
- •?Nodules, papules or plaques as clinical signs consistent with post kala azar dermal leishmaniasis.
排除标准
- •Safety concerns:
- •?Thrombocyte count <100 x 109/l
- •?Leukocyte count <1.5 x 109/l
- •?Hemoglobin < 5.0 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
- •?Major surgery within last 2 weeks
- •?Any non-compensated or uncontrolled condition, such as active tuberculosis, malignant disease, severe malaria, HIV, or other major infectious diseases
- •Lack of suitability for the trial:
- •?Concomitant treatment with other anti-leishmaniasis drugs
研究者
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