ISRCTN63145981已完成4 期
Evaluation of the Efficacy of Artemisinin Combination Therapy in East Africa: A World Bank Multi-country East Africa Public Health Laboratory Networking Project. Rwanda Protocol
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 536
研究概览
简要总结
2019 results in https://doi.org/10.1093/trstmh/trz009
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Aged 1 to 14 years
- •2. A slide-confirmed mono-infection of P. falciparum, asexual parasitemia between 1000 and 100000 p/ul
- •3. Able to attend follow-up visits
- •4. Written informed consent provided by parent or guardian. If the
- •parent/caretaker is illiterate, a witness’ signature and the
- •thumbprint of the participant’s parent/caretaker will be required.
排除标准
- •1. Severe malnutrition
- •2. Co-morbidity including but not limited to: infection, severe anaemia, epilepsy, abnormal cardiac rhythm, hypoglycemia, jaundice, respiratory distress, and recent history of allergy,
- •3. Presence of danger signs including: an inability to drink, vomiting in the past 24 h, an axillary temperature of > 37.5°C or rectal/tympanic temp > 38.0°C, a history of fever within past 24 hours, and/or a recent history of multiple convulsions, unconsciousness, inability to stand or sit
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