Malaria Genetic Surveillance in Cambodia

Completed

• Conditions: Entomology; Malaria; Parasitology

• Registration Number: NCT03384472
• Lead Sponsor: University of Oxford

Brief Summary

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

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2016-06-01
• Study First Submitted: 2016-08-22
• Primary Completion: 2017-02-01
• Study Completion: 2017-02-01
• Status Verified: 2017-12
• Study First Submitted QC: 2017-12-19
• Study First Posted: 2017-12-27
• Last Update Submitted: 2022-05-17
• Last Update Posted: 2022-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 185

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

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Exclusion Criteria

• None

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Annual maps and reports on the prevalence of drug resistance-linked genetic mutations in P. falciparum parasites in Cambodia	up to 12 months

Secondary Outcome Measures

Name	Time	Method
Likely geographic origin of P. falciparum malaria parasites in Cambodia	up to 12 months
Population structure of P.falciparum parasites	up to 12 months	By using population genetics and clustering techniques, such as Principal Component Analysis and phylogeny
Gene flow patterns of P. falciparum malaria parasites in Cambodia	up to 12 months