ISRCTN07576538已完成未知
A randomised, controlled, open-label, parallel-group study comparing the efficacy and safety of an oral artesunate-amodiaquine fixed-dose combination therapy over 3 subsequent days to an equivalent dose regimen of the individual drugs for the treatment of children with Plasmodium falciparum
Drugs for Neglected Diseases initiative (DNDi) (Switzerland)0 个研究点目标入组 890 人开始时间: 2007年11月29日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 890
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. Patient between 6 months and <5 years old
- •2. Bodyweight >= 5 kg (to help the assay of artesunate)
- •3. P. falciparum single-species infection with positive parasitemia (asexual forms) greater than 1,000 parasites per microlitre of blood
- •4. Fever (uncorrected axillary temperature >37.5°C) on Day 0 in children
- •5. No other obvious cause for the fever (e.g., respiratory [ear, nose and/or throat] infection)
- •6. Consent of the child's family or guardian
排除标准
- •1. Signs of life threatening and/or severe malaria
- •2. Other underlying diseases (cardiac, renal, hepatic, severe malnutrition)
- •3. Allergy to the study drugs
- •4. Treatment with amodiaquine within the past 7 days, or with artemisinin derivatives within the past 3 days (72 h)
- •5. Complete cure with an antimalarial within the past 7 days (with the exception of chloroquine)
- •6. On-going treatment with an antibiotic with antimalarial action (e.g. co-trimoxazole, tetracycline, or macrolide)
研究者
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