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临床试验/NCT05072613
NCT05072613已完成不适用

Pregnant Women Attending Antenatal Care Services as a Sentinel Population for Antimalarial Drug Resistance Genetic Surveillance in Africa

University of Oxford1 个研究点 分布在 1 个国家目标入组 6,833 人开始时间: 2021年11月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
6,833
试验地点
1
主要终点
Compare the frequency of Plasmodium falciparum mutations associated with antimalarial drug resistance in the population of pregnant women with that of children.

研究概览

简要总结

Annually, malaria affects an estimated 229 million people, causing 409,000 deaths (WHO 2019) mostly in Africa. Despite a substantial decline in malaria-related maternal and child deaths in recent years, progress in controlling malaria has been slower than anticipated and uneven across countries. COVID-19-related disruption of malaria control activities will likely further slow the pace and lead to an even greater burden in the near future.

One of the greatest challenges delaying progress in malaria elimination is antimalarial drug resistance. Recent reports of the emergence of artemisinin-resistant parasites in parts of Africa are the cause of even greater concern, since the loss of frontline treatment efficacy could bring about a dramatic reversal of progress.

Large-scale genetic surveillance of Plasmodium is an effective tool for rapid detection of changes in drug efficacy, enabling countries to switch to effective preventive and curative treatments when necessary. The implementation of genetic surveillance has proven very successful in small, low malaria burden countries. However, in large, high malaria burden countries such implementation is operationally and economically more complex.

Screening pregnant women attending Antenatal Care (ANC) services can be a practical and economical strategy for estimating malariometric parameters, with fewer limitations and challenges than conventional survey methodologies in children. The present study aims to demonstrate that this is also true for the genetic surveillance of antimalarial drug resistance.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Pregnancy OR for children age <14 years old and in primary school

排除标准

  • Refusal to participate (i.e., consent is not given by the participant for women or by the parents in the case of children)

结局指标

主要结局

Compare the frequency of Plasmodium falciparum mutations associated with antimalarial drug resistance in the population of pregnant women with that of children.

时间窗: 18 months

Plasmodium falciparum from infected individuals will be sequenced and the frequency of antimalarial drug resistance mutations in pregnant women will be compared with that of children.

次要结局

  • Evaluate the acceptability of the intervention(12 months)
  • Compare malaria prevalence in pregnant women with that of in children throughout the year.(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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