ISRCTN88133880已完成不适用
Phase I clinical trial to evaluate the safety and immunogenicity of aluminium hydroxide precipitated autoclaved Leishmania major (Alum-ALM) + Bacillus Calmette-Guerin (BCG) combined with sodium stibo-gluconate (SSG) compared with SSG alone in the treatment of post kala azar dermal leishmaniasis (Sudan)
ICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)0 个研究点目标入组 30 人开始时间: 2005年6月7日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
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
- 性别
- All
入选标准
- •1. Males and females 7 - 60 years
- •2. Skin rash of greater than six months duration following a history of successful treatment for Visceral Leishmaniasis (VL)
- •3. Absence of other skin conditions
- •4. Positive Direct Agglutination Rest (DAT) or rk39
- •5. Willing for hospitalisation at Khartoum for 90 days
- •6. Informed consent
排除标准
- •1. Pregnant or lactating women
- •2. Concurrent/chronic illness
- •3. Known allergy to vaccine components
- •4. Other allergies requiring steroids and Levamisole
- •5. Known immunological deficiency-including human immunodeficiency virus (HIV)
- •6. Concurrent participation in any other drug or vaccine trial
- •7. Known or planned vaccination within one month prior to study
研究者
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