RecruitingPhase 3NCT05690841

FocaL Mass Drug Administration for Vivax Malaria Elimination

FocaL Mass Drug Administration for Vivax Malaria Elimination (FLAME): a Pragmatic Cluster Randomized Controlled Trial in Peru

Sponsor

University of California, San Francisco

Enrollment

7,530 participants

Start Date

Oct 14, 2024

Study Type

INTERVENTIONAL

Conditions

Plasmodium Vivax Malaria Malaria

Summary

FLAME is an open-label cluster-randomized controlled trial that aims to determine the effectiveness of focal mass drug administration (fMDA) to reduce the incidence of Plasmodium vivax malaria in the Loreto Department in Peru. Standard interventions, including symptomatic and asymptomatic screening for malaria infections, provision of insecticide-treated bednets, and environmental transmission monitoring, will be compared to clusters of villages randomized to receive anti-malarial drugs.

Eligibility

Plain Language Summary

Simplified for easier understanding

This study is testing whether a targeted approach — giving malaria prevention medicine to households near a confirmed malaria case — can help eliminate a specific type of malaria (Plasmodium vivax) in communities near Iquitos, Peru. You may be eligible if: - You live in a village within 8 hours of Iquitos, Peru that has had malaria cases in the past year - You live within 200 meters of a household that recently had a malaria case - You are at least 6 months old - Children aged 8–17 must have parental consent plus their own agreement; adults 18+ must consent themselves You may NOT be eligible if: - You have a history of eye or vision problems (for chloroquine) - You have a known allergy to the malaria medicines being used - You are already taking malaria medicine - Your hemoglobin (blood count) is too low (below 9 g/dL) - You are pregnant or breastfeeding an infant with an unknown or low G6PD enzyme level (for tafenoquine or primaquine) - You have a G6PD enzyme deficiency (a genetic condition affecting red blood cells) — this affects eligibility for certain medicines in the study - You have active or severe malaria at the time of enrollment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFocal Mass Drug Administration (fMDA)

Administration of focal mass drug administration for high-risk individuals residing in households that are within 200 meters of a Plasmodium vivax index case households from the prior 2 years (including individuals in the index case household). Intervention to be administered two times, two months apart each cycle, for 3 cycles spaced apart by regular intervals. Each year will include 2 rounds of fMDA. Round 1) Chloroquine (CQ)+ Tafenoquine (TQ) for \>= 16y (CQ: Day1 600 mg, Day 2 600 mg, Day 3 300 mg CQ, TQ 300 mg on Day 1); CQ+ Primaquine (PQ) for \<16y (CQ: age-based dosing, PQ age-based dosing); CQ+PQ for G6PD intermediate individuals \>=6mo and \<16y ((CQ: Day1 600 mg, Day 2 600 mg, Day 3 300 mg, PQ age-based dosing). Round 2) single dose CQ+TQ for \>= 16y (CQ: Day1 600 mg, TQ 300 mg on Day 1); single dose CQ+PQ for \<16y (CQ: age-based dosing, PQ age-based dosing); single dose CQ+PQ for G6PD intermediate individuals \>=6mo and \<16y ((CQ: Day1 600 mg, PQ age-based dosing).

Locations(1)

Asociación Civil Selva Amazónica

Iquitos, Peru

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NCT05690841

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