FocaL mass drug Administration for vivax Malaria Elimination (FLAME): a pragmatic cluster randomized controlled trial in Peru

In most countries approaching elimination, an increasing proportion of malaria infections are caused by Plasmodium vivax (Pv) relative to Plasmodium falciparum (Pf). Mass drug administration (MDA) is recommended for Pf elimination in areas approaching interruption of transmission and where there is good access to treatment, effective implementation of vector control and surveillance, and a minimal risk of re-introduction of infection. Conditional recommendation based on limited evidence has been extended to Pv; however there are still safety and operational challenges with this approach. Focal MDA (fMDA) targets drugs to households at highest risk of infection and can minimize adverse effects of MDA and promote uptake. To test the hypothesis that fMDA, in addition to standard aggressive interventions, will safely reduce transmission, the proposal sets to conduct a 3-year open-label CRCT in the low endemic setting of Loreto Region, Peru.

Eligible villages or clusters will be randomized to control or fMDA. The control arm will receive standard interventions (vector control, symptomatic case management, and active case detection of asymptomatic cases). The treatment arm will receive standard interventions plus fMDA, which will utilize a new drug for radical cure of P. vivax, tafenoquine, and a new quantitative glucose 6 phosphate dehydrogenase (G6PD) deficiency rapid test to support safe administration of tafenoquine. fMDA will be targeted to consenting and eligible high-risk villagers, defined as household members and neighbors of recent Pv index cases. fMDA will be conducted in 2 rounds per year, two months apart for 3 cycles. Eligibility will be re-assessed each year and prior to each fMDA round. 

Project details on ClinicalTrials.govProject details on NIH

Drug-based Strategies
P. vivax

Aug 2022 — May 2027

$1.29M

Peru