NCT00495508已完成4 期
A Randomised, Open-label Non-inferiority Trial of Artemether-lumefantrine Versus Quinine for the Treatment of Uncomplicated Falciparum Malaria During Pregnancy, Mbarara, Uganda (2006-2007)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Epicentre
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- PCR-corrected adequate clinical and parasitological response (ACPR) on Day 42 or at delivery.
研究概览
简要总结
A) for the treatment of uncomplicated malaria during second and third trimester pregnancy to oral Quinine hydrochloride. The PCR-corrected adequate clinical and parasitological response (ACPR) on day 42 is considered as the primary efficacy criterion. Newborns will be followed for growth and development indicators.
详细描述
Study Title:
Efficacy and Safety of Quinine vs Artemether/Lumefantrine in uncomplicated malaria during pregnancy, Mbarara, Uganda (2006/2007).
Regulatory Status:
Investigational - Phase IV
Investigational Product and route:
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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Cohort Study:
- •Weeks of pregnancy between 13 and 22 weeks
- •Resident in Mbarara Municipality (radius of 15km from MNRH)
- •Cohort study signed informed consent form
- •Efficacy Study:
- •Pregnant woman
- •Malaria infection, detected by microscopy, with P. falciparum (mixed or mono-infection)
- •Age of gestation: 13 weeks and beyond
- •Efficacy study signed informed consent form
排除标准
- •Efficacy Study:
- •P. falciparum parasitaemia above 250,000 parasites/μl
- •Severe anaemia
- •Signs or symptoms of severe/complicated malaria requiring parenteral treatment (WHO 2000)
- •Known allergy to artemisinin derivatives, lumefantrine or quinine;
- •Previous participation in the efficacy study
- •Inability to attend the efficacy study follow-up schedule.
研究组 & 干预措施
Quinine
Active Comparator
干预措施: Quinine (Drug)
Arthemeter lumefantrine
Active Comparator
干预措施: artemether / lumefantrine (Drug)
结局指标
主要结局
PCR-corrected adequate clinical and parasitological response (ACPR) on Day 42 or at delivery.
时间窗: 3 years
次要结局
- Pharmacokinetic parameters(3.5 years)
- Incidence of adverse events(3 years)
- Pregnancy outcome(3.5 years)
- Infant development during the first year of life(3 years)
- Histopathological findings in the placenta(4 years)
研究者
研究点 (1)
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