Efficacy of Artesunate-Mefloquine Combination Therapy for the Treatment of Uncomplicated Falciparum Malaria in Trat Province, Thailand
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Determination of parasitological cure rate of directly observed antimalarial therapy
研究概览
简要总结
The main purpose of this study is to compare artesunate-mefloquine combination therapy given for 2 and 3 days at the same total dose for the treatment of uncomplicated falciparum malaria.
详细描述
This will be a randomized, open-label comparison of two versus three days artesunate-mefloquine treatment in patients with uncomplicated falciparum malaria. Primary endpoints will be 63-day parasitological cure rates in the 2 treatment groups. Secondary endpoints will be parasitological failure rates at each of the weekly follow-up visits to Day 56, occurence of treatment-emergent adverse events on days 0, 1 and 2, mefloquine blood concentrations on days 7, 14 and 28, and in vitro drug sensitivity profiles for parasite isolates as measured by inhibitory concentrations. Genotyping of parasites for known markers of drug resistence will be performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 5 to 70 years inclusive. If aged < 18 years the subject must have a parent or guardian in attendance.
- •Asexual stages of P. falciparum parasites in a thick or thin blood film with no other visible plasmodial species.
- •Willing to give informed consent. Parents or guardians of children and adolescents must agree to give informed consent. Assent is necessary in addition to parental informed consent.
- •Able to tolerate oral therapy.
- •Willing to attend follow-up appointments and undergo study procedures.
排除标准
- •History of anti-malarial drug use within the past two weeks or mefloquine (MQ) use within 4 weeks.
- •Bleeding tendency (by history or based on medical records).
- •Severe/complicated malaria as determined by the investigator (coma or seizures, pulmonary edema, shock, renal failure, jaundice, severe anemia, spontaneous bleeding, hyperparasitemia (>5% RBCs infected), or prostration).
- •History of allergy to or intolerance of study medications.
- •Mixed malaria infection by Giemsa stain.
- •Any other condition that in the opinion of the study investigator warrants parenteral antimalarial treatment.
- •Pregnant woman or nursing mother
研究组 & 干预措施
1
2-day oral treatment with: Artesunate 6mg/kg at 0 and 24 hours Mefloquine 25 mg/kg total dose split into 2 doses of 15 mg/kg at 0 hours and and 10 mg/kg given 6-24 hours later Primaquine 0.5 mg/kg single dose at 24 hours
干预措施: Artesunate (Drug)
1
2-day oral treatment with: Artesunate 6mg/kg at 0 and 24 hours Mefloquine 25 mg/kg total dose split into 2 doses of 15 mg/kg at 0 hours and and 10 mg/kg given 6-24 hours later Primaquine 0.5 mg/kg single dose at 24 hours
干预措施: Mefloquine (Drug)
2
3 days oral treatment with: Artesunate 4 mg/kg/day for 3 days Mefloquine 8 mg/kg/day for 3 days Primaquine 0.5 mg/kg single dose at 24 hours
干预措施: Artesunate (Drug)
2
3 days oral treatment with: Artesunate 4 mg/kg/day for 3 days Mefloquine 8 mg/kg/day for 3 days Primaquine 0.5 mg/kg single dose at 24 hours
干预措施: Mefloquine (Drug)
结局指标
主要结局
Determination of parasitological cure rate of directly observed antimalarial therapy
时间窗: 63 days from initiation of treatment
次要结局
- Parasitological cure rates(Weekly to Day 56)
- Occurence of treatment-emergent adverse events(3 days)
- In vitro drug sensitivity profile for individual parasite isolates(Baseline)
- Mefloquine whole blood concentrations(28 days)
研究者
Douglas Walsh
Dept Chief
Armed Forces Research Institute of Medical Sciences, Thailand