PACTR202003802011316已完成3 期
Efficacy and safety of artemisinin-based combination therapy and the implications of Pfkelch13 and Pfcoronin molecular markers in treatment failure in Senegal
未提供0 个研究点目标入组 500 人开始时间: 2020年3月9日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 500
研究概览
简要总结
A total of 496 patients were enrolled. In Diourbel, PCR non-corrected/corrected adequate clinical and parasitological responses (ACPR) was 100.0% in both AL and ASAQ arms. In Kedougou, PCR corrected ACPR were 98.8%, 100% and 97.6% in AL, ASAQ and DP arms respectively. No Pfk13 or Pfcoronin mutation associated to artemisinin resistance was found. This study showed that AL, ASAQ and DP remain efficacious and well tolerated in the treatment of uncomplicated falciparum malaria in Senegal.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 Year(s) 至 5 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged 6 months or above, had an axillary temperature = 37.5 °C at presentation or history of fever during the last 24 hours,
- •a positive P. falciparum mono-infection parasitemia of 1,000 to 100,000 asexual forms/ul,
- •ability to swallow oral medication,
- •ability and willingness to comply with the study protocol and visit schedule for the duration of the study,
- •written informed consent from the patient or from the parent or guardian for enrolled children
排除标准
- •presence of general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the definitions of WHO ,
- •mixed or mono-infection with another Plasmodium species detected by microscopy,
- •positive pregnancy test, severe malnutrition,
- •febrile conditions due to diseases other than malaria or other known underlying chronic or severe diseases, regular medication, which may interfere with anti-malarial treatment, history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s).
研究者
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