ACTRN12610000130066已完成2 期
Efficacy and safety of liposomal amphotericin B in Nepalese patients with visceral leishmaniasis.
The United Nations Children's Fund (UNICEF)/ The United Nations Development Programme (UNDP) /World Bank /World Health Organization (WHO) Special Programme for Research and Training in Tropical Diseases (TDR)0 个研究点目标入组 35 人开始时间: 2010年2月9日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 2 Years 至 65 Years（—）
- 性别
- All
入选标准
- •1 Children and adults of ages between 2 and 65 years (inclusive)
- •2 Fever for more than two weeks
- •3 Splenomegaly
- •4 rK39 rapid test positive
- •5 Confirmed diagnosis of VL by visualization of parasites on splenic aspirate
- •6 Biochemical and haematological test values as follows
- •-Haemoglobin equal/greater than 6 g/dl
- •-White blood cell count equal/ greater than 1.0 x 109/L
- •-Platelets equal/greater than 50 x109/L
- •-Prothrombin time equal /lower than 5 sec above control
- •-Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) equal/lower than 3 times the upper limit of normal
- •-Bilirubin equal/lower than 1.5 times the upper limit of normal
- •-Serum creatinine level within normal limit
- •7 immunodeficiency virus antibody test (HIV) negative serology
- •8 Written informed consent from the patient/or from parent or guardian if under 18 years old
排除标准
- •1. A history of intercurrent or concurrent diseases (e.g. Chronic alcohol consumption or drug addiction, renal, hepatic, cardiovascular or Central Nervous System (CNS) disease; diabetes mellitus, other infectious diseases or major psychiatric diseases) that may introduce variables that affect the outcome of the study
- •2. Any condition which according to the investigator might prevent the patient from completing the study therapy and subsequent follow up
- •3. A history of allergy or hypersensitivity to Amphotericin B
- •4. Previous treatment for VL within two months of enrolment into the study
- •5. Prior treatment failure with Amphotericin B
- •6. Post Kala-azar Dermal Leishmaniasis (PKDL)
- •7. Concomitant treatment with other anti-leishmanial drugs
- •8. Pregnant women or lactating mother
研究者
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