ACTRN12612000367842招募中4 期
Proof of concept to determine the feasibility of single dose liposomal Amphotericin B for the treatment of Visceral Leishmaniasis patients at Upazila level in Bangladesh
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 300
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
- 5 Years 至 o limit（—）
- 性别
- All
入选标准
- •Male or female patients 5 or more years of age
- •History of fever for more than 2 weeks
- •Splenomegaly
- •rK 39 rapid test positive done by the study team
- •Hemoglobin equal or greater than 5 g/dl
排除标准
- •A history of intercurrent or presence of clinical signs / symptoms of concurrent diseases / conditions not under control before starting the treatment with liposomal amphotericin B (AmBisme).
- •Any condition which according to the investigator might prevent the patient from completing the study therapy and subsequent follow up
- •A history of allergy or hypersensitivity to amphotericin B
- •Previous treatment for VL within two months of enrolment into the study
- •Prior treatment failure with amphotericin B
研究者
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