CTRI/2017/09/009594招募中未知
A multi-centre, open-label randomised trial to assess the effi-cacy, safety and tolerability of Triple Artemisinin-based Combination Therapies (TACTs) compared to Artemisinin-based Combination Therapies (ACTs) in uncomplicated fal-ciparum malaria and to map the geographical spread of artemisinin and partner drug resistance.
K Department for International Development DFID0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
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
入选标准
- •Acute uncomplicated P. falciparum malaria confirmed by positive blood smear with asexual forms of P. falciparum
- •Asexual P. falciparum parasitaemia: 5,000 to 200,000/uL, determined on a thin or thick blood film
- •Fever defined as > 37.5°C tympanic temperature or a history of fever within the last 24 hours
- •Written informed consent (by parent/guardian in case of chil-dren)
- •Willingness and ability of the patients or parents/guardians to comply with the study protocol for the duration of the study
排除标准
- •Signs of severe/complicated malaria
- •Haematocrit < 25% or Hb < 8 g/dL at enrollment
- •Acute illness other than malaria requiring treatment
- •For females: pregnancy, breast feeding
- •Patients who have received artemisinin or a derivative or an artemisinin-containing combination therapy (ACT) within the previous 7 days
- •Antimalarial therapy in past Two months
- •Previous splenectomy
- •Documented or claimed history of cardiac conduction prob-lems
- •Earlier participation within the TRACII trial or another trial in the previous 3 months.
研究者
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