ISRCTN68386084已完成不适用
A phase III multicentre, randomised, controlled, clinical trial to assess the safety and efficacy of injectable paromomycin in patients with visceral leishmaniasis (India)
ICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)0 个研究点目标入组 667 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
- 667
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. Aged 5 to 55 years (inclusive) of either gender
- •2. Confirmed diagnosis by spleen or bone marrow aspirate
- •3. Clinical signs and symptoms compatible with VL
- •4. Lab tests:
- •4.1. Haemoglobin more than 5.0/100 ml
- •4.2. White Blood Cell (WBC) count more than 1 x 10^9 l
- •4.3. Platelet count more than 50 x 10^9 l
- •4.4. Aspartate transaminase (AST), alanine transaminase (ALT) and Alkaline Phosphatase less than three times upper normal limit
- •4.5. Prothrombin time less than five seconds above control
- •4.6. Serum creatinine within normal limits
- •4.7. Serum potassium within normal limits
- •5. Human Immunodeficiency Virus (HIV) negative
排除标准
- •1. History of intercurrent or concurrent diseases that may introduce variable that affect the outcome of the study
- •2. Any condition which the investigator thinks may prevent the patient from completing the study therapy
- •3. An abnormal baseline audiogram and/or a history of vestibular or auditory dysfunction
- •4. Proteinuria (more than 2 g/day)
- •5. A history of hypersensitivity or allergy to aminoglycosides
- •6. History of major surgery within last two weeks
- •7. Pregnancy or lactation
- •8. Previous treatment for VL within two weeks of enrolment into the study
- •9. Prior treatment failures with paromomycin or amphotericin B
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