Malaria Genetic Surveillance

NCT ID: NCT03384498

Last Updated: 2022-03-23

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 30000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2023-01-31

Brief Summary

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

Detailed Description

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.

Conditions

Plasmodium Falciparum and Plasmodium Vivax

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• None

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Oxford

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

National Centre for Malaria Control, Parasitology and Entomology (CNM)

Phnom Penh, , Cambodia

Site Status: RECRUITING

Center of Malariology, Parasitology and Entomology

Vientiane, , Laos

Site Status: RECRUITING

Institute of Malariology, Parasitology, and Entomology Quy Nhon

Qui Nhon, , Vietnam

Site Status: RECRUITING

Countries

Cambodia; Laos; Vietnam

Central Contacts

Olivo Miotto, MD

Role: CONTACT

Olivo@tropmedres.ac

Facility Contacts

Dr. Siv Sovannaroth

Role: primary

Dr. Viengxay Vanisaveth

Role: primary

Dr. Nhien Nguyen Thanh Thuy, MD

Role: primary

Other Identifiers

BIOINF1602

Identifier Type: -

Identifier Source: org_study_id