Performance and safety of point-of-care glucose-6-phosphate dehydrogenase enzyme activity assays to guide administration of primaquine radical cure therapy for Plasmodium vivax malaria in western Cambodia.

The primary objective of the study is to assess the performance of up to three novel POC assays designed to detect G6PD enzyme deficiency in the field. The assessment of up to two quantitative G6PD assays available at the time of the study (Carestart and/or SD Biosensor) will be done, potentially alongside a novel, qualitative, lateral flow RDT. Field performance of each assay will be compared to that of the gold standard spectrophotometric approach to determine the diagnostic capabilities of each POC method studied in this population. Currently available field diagnostics in Cambodia severely restrict the ability for primaquine/tafenoquine to be effectively used; even the upcoming pilot to determine the safety of primaquine administration following a field rollout of G6PD RDTs is limited to men due to the complexities of qualitative assay interpretation for women. The findings from this evaluation will serve to provide data to Cambodian officials that these novel tools are capable of providing actionable information in the field allowing for the safe administration of primaquine for radical cure of P. vivax malaria beyond adult males when warranted. 

This study consists of two separate, but related surveys to assess field performance of quantitative assays measuring G6PD activity. Phase 2 will be contingent upon Phase 1 results to ensure participant safety is a priority at all times. The surveys to be conducted include Phase 1) a cross-sectional, community-based survey among healthy individuals and Phase 2) a prospective, health care facility-based survey among those self-presenting for medical attention with febrile illness. Treatment for individuals with confirmed P. vivax malaria in Phase 2 will be provided primaquine as radical cure if G6PD POC testing confirms normal enzyme activity levels. 

P. vivax

Apr 2020 — May 2021

$400,000

Cambodia