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临床试验/NCT03648411
NCT03648411已完成不适用

Assessment of Drug Resistance Molecular Markers in Asymptomatic Malaria Among Migrant Workers in Myanmar

Department of Medical Research, Lower Myanmar1 个研究点 分布在 1 个国家目标入组 765 人开始时间: 2019年1月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
765
试验地点
1
主要终点
Prevalence of the asymptomatic infection among the study population

研究概览

简要总结

A cross-sectional study will be conducted in selected 2 sentinel sites for assessment of drug resistance falciparum and vivax among asymptomatic infection in migrant workers in Myanmar.

详细描述

Although malaria prevalence is decreasing in Myanmar, drug resistance threatens the malaria elimination by 2030 especially high risk persons including migrant population. Previous study indicated that asymptomatic malaria parasite carried drug resistance gene such as K13 mutant that is genetically responsible for artemisinin resistant falciparum malaria. These asymptomatic carries may be a source to spread the disease and it is very important to conduct the surveillance on drug resistance status among high vulnerable persons. Unfortunately, there is no study to assess the drug resistance molecular markers in asymptomatic malaria among migrant workers in Myanmar. Therefore, this study fulfills the gaps of knowledge on important of asymptomatic hidden infection exploring to formulate the recommendation for elimination of malaria in Myanmar.

In this study, asymptomatic infections are screened by rapid diagnostic test, microscopy and molecular methods.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age above 6 year
  • Migrant population (moving from their normal residence place and working at a new place such as forest related activities, gold-mines or plantation sites for more than 3 months- 3 years)
  • Participant who give informed-consent to participate the study

排除标准

  • Known clinical malaria cases regardless of the species detected
  • Patients with clinical symptoms of malaria at the time of examination
  • Known history of malaria within 14 days

结局指标

主要结局

Prevalence of the asymptomatic infection among the study population

时间窗: 1 week

Number of the hidden malaria cases by RDT, microscopy or nested PCR (molecular method)

Proportion of the drug resistance molecular markers among asymptomatic infections

时间窗: 3 months

Among the asymptomatic cases, molecular markers will be analyzed (K13 and pfmdr1 copy number for falciparum and pvcrt-o, pvmdr1, pvdhps and pvdhfr gene analysis for vivax cases by Sanger Sequencing.

次要结局

未报告次要终点

研究者

发起方
Department of Medical Research, Lower Myanmar
申办方类型
Other
责任方
Principal Investigator
主要研究者

Myat Htut Nyunt

Principal Investigator

Department of Medical Research, Lower Myanmar

研究点 (1)

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