An Evaluation of Sulfadoxine-pyrimethamine Resistance and Effectiveness of IPTp in Nigeria
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- To determine the efficacy of SP-IPTp for clearing peripheral malaria parasiteamia in asymptomatic primi and secondi gravid women
研究概览
简要总结
The study has two components: component A is a cohort study to determine the in vivo efficacy of SP to clear and prevent malaria parasitaemia in asymptomatic pregnant women and component B is a cross sectional study of women delivering at the study hospitals to assess the effectiveness of SP-IPTp to reduce adverse maternal and birth outcomes in the current context of increasing SP resistance. Results of component A and B studies will be used to model the relationship between the prevalence of molecular markers of SP resistance, in vivo efficacy to clear parasite and the effectiveness of SP-IPTp and to develop guidelines for routine monitoring effectiveness of SP-IPTp as part of ANC surveillance.
详细描述
Study sites will include different levels of transmission and social factors affecting ANC attendance Damboa hospital in Borno state has a catchment area with pop of 231,573 with a semi arid climate and where malaria is mesoendemic. The expected number of patients is 15-25 per week for new bookings Park Lane hospital serves a semiurban population. Malaria transmission is holoendemic and stable. 1400 women attend ANC services per month Women will receive SP-IPTp according to National guidelines and will be followed for 42 days to assess the therapeutic efficacy in parasitaemic women and to assess the ability to remain parasite free. PCR will be used to determine reinfection from recrudescence
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •gestational age 16-30 weeks
- •Axillary temperature ,37.5 Degrees
- •informed consent
排除标准
- •gravida > 2
- •previous inclusion in this study
- •history of hypersensitivity to SP or components of SP
- •Use of IPTp with SP during this pregnancy
- •history of taking other antimalarials in the past month
- •Known HIV infection
研究组 & 干预措施
SP-IPTp efficacy
Efficacy of suphladoxine/pyrimethamine as IPTp
干预措施: Efficacy of suphladoxine/pyrimethamine as IPTp (Drug)
结局指标
主要结局
To determine the efficacy of SP-IPTp for clearing peripheral malaria parasiteamia in asymptomatic primi and secondi gravid women
时间窗: 15 months
PCR corrected Adequate parasitological clearance by day 42
次要结局
- To determine the efficacy of SP-IPTp in preventing new infections in primi- and secundi-gravid women(15 months)
- To estimate the prevalence of molecular markers of SP resistance in primi- and secundi-gravid women(15 months)