临床试验/NCT00164255

NCT00164255已完成4 期

Efficacy of Intermittent Sulfadoxine-Pyrimethamine and Sulfadoxine-Pyrimethamine + Artesunate Treatment in the Prevention of Malaria in Pregnancy in an Area With Chloroquine-Resistant Plasmodium Falciparum

Centers for Disease Control and Prevention2 个研究点分布在 1 个国家目标入组 1,614 人开始时间: 2003年1月1日最近更新: 2012年9月11日

适应症

试验速览

阶段: 4 期
状态: 已完成
发起方: Centers for Disease Control and Prevention
入组人数: 1,614
试验地点: 2
主要终点: reported or noted adverse reactions

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is an investigation to compare the efficacy of two different intermittent sulfadoxine/pyrimethamine (SP) treatment regimens and intermittent sulfadoxine/pyrimethamine (SP) + artesunate (SP/AS) treatment of HIV negative and positive mothers in clearing placental parasitemia at delivery. If intermittent protective SP/AS treatment is equally efficacious and safe as intermittent protective SP, such a regimen could be adapted for programmatic use as a potentially more durable alternative to SP monotherapy in areas of increasing SP resistance.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Prevention
盲法: None

入排标准

年龄范围: 15 Years 至 —（Child, Adult, Older Adult）
性别: Female
接受健康志愿者: 是

入选标准

•Women 15 years of age or older
•First or second pregnancy between 16 and 36 weeks gestation

排除标准

•Pregnancy prior to 16 weeks or after 36 weeks gestation
•Third or later pregnancy;
•Report previous allergic reactions to SP, AS, or unknown antimalarials;
•If the distance to their home is too great or too inaccessible for follow-up;
•Child's father refuses the woman's participation

结局指标

主要结局

reported or noted adverse reactions

placental parasitemia

次要结局

parasitemia at delivery (maternal peripheral, placental and cord)
maternal illness
birth weight
gestational age
fetal and infant health
impact of maternal HIV infection on efficacy of malaria prevention during pregnancy

研究者

发起方

Centers for Disease Control and Prevention

申办方类型

Fed

责任方

Sponsor

研究点 (2)

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