NCT03217851

Prevalence Survey of Antimalarial Drug Resistance Markers

Prevalence Survey of Plasmodium Falciparum Antimalarial Drug Resistance Markers in Greater Mekong Subregion

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 4,000 (actual)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 6 Months – 75 Years
• Healthy volunteers: Not accepted

Summary

Study is cross-sectional and observational with one-time dried-blood spot sample collection from persons with laboratory-confirmed uncomplicated Plasmodium falciparum malaria (mixed or monoinfection). Samples will be analysed for the presence of molecular markers of resistance to ACT partner drugs (gene amplifications and/or other mutations in pfmdr1, gene amplifications of pfpm2, and additional mutations which may be identified during the course of the trial) in the first instance. Testing to detect additional markers of antimalarial drug resistance will also be performed where feasible. Prevalence of mutations will be summarized and mapped to provide intelligence on antimalarial drug resistance in the region of interest.

Detailed description

Malaria Malaria is caused by a mosquito-borne, protozoan parasite belonging to the genus Plasmodium. Of the five species of Plasmodium that infect humans, Plasmodium falciparum is the most deadly and is responsible for the majority of malaria disease and death. Every year, falciparum malaria causes disease in hundreds of millions of people living in the tropics and subtropics, killing a million or more according to some estimates. The vast majority of these deaths occur in sub-Saharan Africa, mostly among young children and infants. When treated with effective antimalarial drugs, malaria can be cured completely. Antimalarial drug resistance The emergence in Southeast Asia and the subsequent global spread of drug resistant malaria was a major factor contributing to the failure of the first global malaria eradication campaign in the mid-20th century (1). The widespread implementation of highly effective artemisinin-based combination therapy (ACT) for malaria has contributed to significant gains in global control and elimination efforts and has brought malaria eradication back on the agenda, 40 years after the first global malaria eradication campaign was abandoned (2). However the gains seen in the past decade are now at risk as parasite resistance to artemisinin compounds has been confirmed in Southeast Asia and threatens Africa once again (3-8). In the absence of effective vaccines, it is critical to prolong the usable life of antimalarial drugs by judicious implementation of treatment strategies. Primary Objective To measure prevalence of established and candidate molecular markers of drug resistant malaria in Greater Mekong Subregion Secondary Objective To map the geographical and temporal changes in prevalence of molecular markers of antimalarial drug resistance in Greater Mekong Subregion Funder: EXPERTISE FRANCE Grant reference number: Expertise France reference 15SANIN211

Conditions

• Malaria

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Blood Collection	blood smear and/or rapid diagnostic
DIAGNOSTIC_TEST	Dried Blood Spot	Dried Blood Spot on filter paper

Timeline

• Start date: 2017-09-18
• Primary completion: 2021-12-24
• Completion: 2021-12-24
• First posted: 2017-07-14
• Last updated: 2022-06-28

Locations

1 site across 1 country: Thailand