ACTRN12617000329369已完成4 期
A comparison of two artemisinin combination therapies (ACTs) in combination with primaquine for radical cure of Plasmodium vivax malaria in the Solomon Islands
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 383
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
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 12 Months 至 o limit（—）
- 性别
- All
入选标准
- •1.Age over 12 months
- •2.Weight greater than or equal to 10kg
- •3.Melanesian background and living in local area
- •4.Microscopically (based on field microscopy) or RDT confirmed P.vivax regardless of parasite density. Mixed infections (P.falciparum-P.vivax) can be included.
排除标准
- •1.Any signs of severe malaria (see WHO definitions) including: impaired consciousness, respiratory distress, severe anaemia (Hb<5), multiple seizures, frequent vomiting/ inability to swallow tablets, prostration, jaundice, hypotension, abnormal bleeding or hypoglycaemia.
- •2.Clinical evidence of non-malarial illness (such as pneumonia or otitis media)
- •3.Severe malnutrition (weight-for-age nutritional Z score [WAZ] <60th percentile)
- •4.Permanent disability, which prevents or impedes study participation.
- •5.Treatment with PQ in the previous 14 days
- •6.Residence or planned travel outside the study area during the follow-up period (precluding supervised treatment and follow-up procedures)
- •7.Known or suspected pregnancy
- •8.Currently breastfeeding
- •9.A positive rapid test for G6PD deficiency (Binax (Trademark) or Carestart (Trademark) RDT)
研究者
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