Pseudo-randomised, Double-blinded Placebo-controlled Trial of Chloroquine or Sulphadoxine-pyrimethamine Alone or in Combination With Primaquine or Artesunate for the Treatment of Uncomplicated Falciparum Malaria in Pakistan
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 588
- 试验地点
- 1
- 主要终点
- Parasitological outcome after 28 days follow-up
研究概览
简要总结
This study is an evaluation of the benefit of adding artesunate to existing first and second line antimalarial therapies in Pakistan.
A placebo controlled trial was carried out to assess two potential benefits of Artesunate Combination Therapy (ACT): efficacy and potential for transmission reduction.
详细描述
A randomised, double-blind placebo controlled study of the efficacy of chloroquine or sulphadoxine-pyrimethamine alone and in combination with primaquine or artesunate for the treatment of uncomplicated falciparum malaria.
Arms:
- CQ
- CQ+primaquine
- CQ+ artesunate
- SP
- SP+primaquine
- SP+artesunate
Patients were allocated to treatment groups using a pseudo-randomised table split by age and sex.
Primary outcomes:
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •presentation at basic health unit with suspected clinical malaria
- •mono-infection infection with P. falciparum confirmed by microscopy
- •over 2 years of age (no upper age restriction)
- •weight over 5 kg (no upper weight restriction)
- •if of child bearing age then non-pregnant and willing to remain so for the duration of the study
- •greater than 1 asexual parasite per 10 fields
- •understands and is willing to sign the consent form
- •a resident in the study site willing to collaborate for a full period of follow-up
- •no signs of severe malaria
排除标准
- •other serious disease (e.g., cardiac, renal or hepatic)
- •in women of child bearing age, pregnancy
- •allergy to any of the study drugs or related compounds
- •reports to have used any malaria drugs in the last 21 days
- •other species of malaria seen
- •signs of severe malaria
研究组 & 干预措施
SP
干预措施: sulphadoxine-pyrimethamine (SP) (Drug)
CQ
干预措施: Chloroquine (CQ) (Drug)
CQ+PQ
干预措施: Chloroquine (CQ) (Drug)
CQ+PQ
干预措施: primaquine (PQ) (Drug)
CQ + AS
干预措施: artesunate (AS) (Drug)
CQ + AS
干预措施: Chloroquine (CQ) (Drug)
SP + PQ
干预措施: sulphadoxine-pyrimethamine (SP) (Drug)
SP + PQ
干预措施: primaquine (PQ) (Drug)
SP + AS
干预措施: artesunate (AS) (Drug)
SP + AS
干预措施: sulphadoxine-pyrimethamine (SP) (Drug)
结局指标
主要结局
Parasitological outcome after 28 days follow-up
时间窗: 28 days
次要结局
- Asexual parasite clearance by day 7(7 days)
- Gametocyte carriage on or after day 7(7 days)