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Malaria Genetic Surveillance in Cambodia

2022年5月17日 更新者:University of Oxford

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

This study is to determine the prevalence and geographical distribution of antimalarial drug resistance-linked genetic mutations in clinical P. falciparum infections in Cambodia

研究概览

地位

完全的

详细说明

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.

研究类型

观察性的

注册 (实际的)

185

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

6个月 及以上 (孩子、成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Patients > 6 months of age with P. falciparum malaria who present to village malaria workers and health centres in Stung Treng and Ratanakiri provinces in Cambodia are the target study population. 2014 data suggest this could amount to up to 7,000 patients per year. All study participants must satisfy the applicable inclusion and exclusion criteria

描述

Inclusion Criteria:

  • 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

Exclusion Criteria:

• None

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Annual maps and reports on the prevalence of drug resistance-linked genetic mutations in P. falciparum parasites in Cambodia
大体时间:up to 12 months
up to 12 months

次要结果测量

结果测量
措施说明
大体时间
Population structure of P.falciparum parasites
大体时间:up to 12 months
By using population genetics and clustering techniques, such as Principal Component Analysis and phylogeny
up to 12 months
Gene flow patterns of P. falciparum malaria parasites in Cambodia
大体时间:up to 12 months
up to 12 months
Likely geographic origin of P. falciparum malaria parasites in Cambodia
大体时间:up to 12 months
up to 12 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2016年6月1日

初级完成 (实际的)

2017年2月1日

研究完成 (实际的)

2017年2月1日

研究注册日期

首次提交

2016年8月22日

首先提交符合 QC 标准的

2017年12月19日

首次发布 (实际的)

2017年12月27日

研究记录更新

最后更新发布 (实际的)

2022年5月24日

上次提交的符合 QC 标准的更新

2022年5月17日

最后验证

2017年12月1日

更多信息

与本研究相关的术语

其他研究编号

  • BIOINF1601

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

Anonymised data recorded in the CRFs will be shared via open access online repositories as per the requirements of the journal in which the results of the study are published.

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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