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临床试验/NCT03384498
NCT03384498Unknown不适用

Genetic Epidemiology of Malaria and Associated Antimalarial Drug Resistance

University of Oxford3 个研究点 分布在 3 个国家目标入组 30,000 人开始时间: 2016年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
30,000
试验地点
3
主要终点
Annual maps and reports on the prevalence of drug resistance-linked genetic mutations in P. falciparum parasites in the Greater Mekong Subregion

研究概览

简要总结

This study is to determine the prevalence and geographical distribution of antimalarial drug resistance-linked genetic mutations in clinical P. falciparum and/or P.Vivax infection in the Greater Mekong Subregion

详细描述

This is a prospective observational study of patients with clinical Plasmodium falciparum and/or Plasmodium Viviax infection using parasite DNA from point-of-care fingerprick dried blood spot samples as well as a short survey on patient demographics, employment, travel, and mobile phone use to study P. falciparum parasite genotypes, population characteristics, and gene flow patterns.

On inclusion in the study and before standard treatment is administered, dried blood spots (DBS) will be obtained through fingerprick blood sampling from patients, with two or three blood spots on one piece of filter paper being obtained from each patient. Each blood spot will contain ~20µl of blood, for a total of ~ 40-60 uL of blood being collected from each patient for the study.

In order to have a greater understanding of the possible sites of malaria transmission and to relate genetic diversity to geographic location, patients or their parents/guardians will also be asked a short set of questions on demographics, their places of residence and work, recent mobile phone use, and their history of travel. The basic questions on phone utilisation will provide information on the use of mobile phones in the study population, including which mobile phone companies are used, and how many SIM cards and handsets each person carries. It will be employed to derive information on population movement from anonymised, aggregated data on mobile phone telephone use, i.e. call detail records (CDR), obtained from mobile phone companies in each country. This will be used for the modelling of population movement, its impact on the distribution of malaria and antimalarial drug resistance, and subsequent prediction of potential routes of spread of malaria and antimalarial drug resistance. As some of this information can be sensitive, during the consent process the patient will be given the option of not providing some or all of this information without needing to provide a reason. For those who do not wish to provide information, this will be documented in the survey form. A duplicate of the sample barcode will be placed on this same form, so the information therein can be matched with the relevant blood spot and its related genetic data, while retaining sample anonymity.

All patients in the study will receive standard care for falciparum malaria including drug therapy according to the national treatment guidelines of their country.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Male or female of any age
  • P. falciparum and/or P.Vivax malaria as confirmed by positive rapid diagnostic test or asexual forms of P. falciparum on blood smear microscopy (may be mixed with non-falciparum Plasmodium species)
  • Written informed consent by patient, parent/guardian, or legally authorised representative to participate in the study

排除标准

  • 未提供

结局指标

主要结局

Annual maps and reports on the prevalence of drug resistance-linked genetic mutations in P. falciparum parasites in the Greater Mekong Subregion

时间窗: up to 12 months

次要结局

  • Allelic variations associated to drug resistance in P. falciparum at the locations surveyed(up to 12 months)
  • Allelic variations associated to drug resistance in P. vivax at the locations surveyed(up to 12 months)
  • Genetic differentiation between parasites populations at different locations in the Greater Mekong Subregion(up to 12 months)
  • Population structure of parasites(up to 12 months)
  • Gene flow patterns of P. falciparum malaria parasites in the Greater Mekong Subregion(up to 12 months)
  • Likely geographic origin of P. falciparum malaria parasites in the Greater Mekong Subregion(up to 12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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