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临床试验/NCT03384472
NCT03384472已完成不适用

Integrating Genetic Epidemiology as an Intensified Surveillance Tool Into the National Centre for Parasitology, Entomology and Malaria Control of Cambodia

University of Oxford0 个研究点目标入组 185 人开始时间: 2016年6月1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
185
主要终点
Annual maps and reports on the prevalence of drug resistance-linked genetic mutations in P. falciparum parasites in Cambodia

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 infections in Cambodia

详细描述

This is a prospective observational study of patients with clinical Plasmodium falciparum 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 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 ~60µl 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 in the last 2 months. 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. This is explained on the patient information sheet. For those who do not want 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.

研究设计

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

入排标准

年龄范围
6 Months 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female >6 months of age
  • P. falciparum 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 Cambodia

时间窗: up to 12 months

次要结局

  • Likely geographic origin of P. falciparum malaria parasites in Cambodia(up to 12 months)
  • Population structure of P.falciparum parasites(up to 12 months)
  • Gene flow patterns of P. falciparum malaria parasites in Cambodia(up to 12 months)

研究者

申办方类型
Other
责任方
Sponsor

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