Efficacy of Artesunate-amodiaquine (ASAQ) and Artemether-lumefantrine (AL) for the Treatment of Uncomplicated Plasmodium Falciparum Malaria in Liberia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 352
- 试验地点
- 2
- 主要终点
- Number of Participants with Late Treatment Failure (LTF)
研究概览
简要总结
To assess the efficacy of both first-line antimalarial medications used for the treatment of uncomplicated Plasmodium falciparum malaria infections in two geographic regions in Liberia.
详细描述
Title: Efficacy of artesunate+amodiaquine (ASAQ) and artemether+lumefantrine (AL) for the treatment of uncomplicated Plasmodium falciparum malaria in Liberia
Objective: To assess the efficacy of both first-line ASAQ and AL for the treatment of uncomplicated P. falciparum malaria infections
Study Sites: Sacleapea Comprehensive Health Center, Saclepea-Mah District in Nimba County; and Sinje Health Center, Garwula District, Sinje, in Grand Cape Mount County
Study Period: August 2022 to August 2023
Study Design: Prospective study of two cohorts with simultaneous enrolment of each therapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 59 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Artesunate+Amodiaquine (ASAQ)
Amodiaquine-artesunate (ASAQ) dose based on weight, given once daily for three days.
ASAQ has three formulations, with the dose depending on the weight of the child according to the following.
4.5-8.9 kg = 1 tablet 25 mg AS/67.5 mg AQ 9-17.9kg = 1 tablet 50 mg AS/135 mg AQ 18.0-35.9kg = 1 tablet 100 mg AS/270 mg AQ
≥36.0kg = 2 tablets 100 mg AS/270 mg AQ
干预措施: Amodiaquine-artesunate (ASAQ) (Drug)
Artemether+Lumefantrine (AL)
Artemether+Lumefantrine (AL) dose is based on weight and given twice daily for three days. AL has one formulation, with pills containing 20 mg artemether and 120 mg lumefantrine. The number of tablets per dose depends on the weight of the child according to the following:
5 -14.9 kg = 1 tablet per dose 15 -24.9 kg = 2 tablets per dose 25 -34.9 kg = 3 tablets per dose
≥35 kg = 4 tablets per dose
1 tablet contains 20 mg artemether and 120 mg lumefantrine
干预措施: Artemether+Lumefantrine (AL) (Drug)
结局指标
主要结局
Number of Participants with Late Treatment Failure (LTF)
时间窗: Day 4 to day 28 following treatment.
* Danger signs, signs of severe malaria, or axillary temperature \> 37.5 °C in the presence of parasitemia on any day between day 4 and day 28 in patients who did not previously meet any of the criteria of early treatment failure * Presence of parasitemia (with a parasite with the same genotype as day 0) on any day between day 7 and day 28 regardless of temperature in patients who did not previously meet any of the criteria of early treatment failure
Number of Participants with Adequate Clinical and Parasitological Response (APCR)
时间窗: Day 28 following treatment.
• Absence of parasitemia on day 28, irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure, late clinical failure, reinfection or late parasitological failure.
Number of Participants with Early Treatment Failure (ETF)
时间窗: Day 1 to day 3 following treatment.
* Danger signs or severe malaria on day 1, 2, or 3 in the presence of parasitemia * A parasitemia on day 2 higher than day 0 * Axillary temperature ≥ 37.5 °C on day 3 in the presence of parasitemia * Parasitemia on day 3 ≥ 25% of day 0 parasitemia
次要结局
- Number of Patients with Adverse Events(During participation in the study, approximately 4 weeks.)
研究者
Jonathan Schultz
Medical Officer
Centers for Disease Control and Prevention