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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 3INTERVENTIONAL

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

FocaL Mass Drug Administration for Vivax Malaria Elimination (NCT05690841) is a Phase 3 interventional studying Plasmodium Vivax Malaria and Malaria, sponsored by University of California, San Francisco. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Plasmodium Vivax Malaria, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 7,530 participants makes this one of the larger Plasmodium Vivax Malaria trials currently registered. Trials at this scale are typically global, run across many sites, and designed to generate the definitive evidence package for an FDA approval submission or a label expansion.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Cluster eligibility - Within 8 hours transport of Iquitos - Incidence \<250/1000 and \>2 cases year prior to trial - Population size (\<650) 2. Chloroquine (CQ) eligibility - Resides in neighboring household but within 200 m of Pv index case in the past 2 years - Age ≥6 months old - Present for intervention - Adult ≥18 years old that provides willing to sign a consent form - A child ≥8 years and \<18 years old that provides informed assent and has willing to sign a consent form from their parents - A child ≥6 months old and \<8 years old that has willing to sign a consent form from their parents 3. Tafenoquine (TQ) eligibility - Eligible to receive CQ - Age ≥16 years old - Adult ≥18 years old that provides willing to sign a consent form - A child ≥16 years and \<18 years old that provides informed assent and has willing to sign a consent form from their parents 4. Primaquine eligibility - Eligible to receive CQ and ineligible to receive TQ - Age ≥6 months old - Adult ≥18 years old that provides willing to sign a consent form - A child ≥8 years and \<18 years old that provides informed assent and has willing to sign a consent form from their parents - A child ≥6 months old and \<8 years old that has willing to sign a consent form from their parents 5. Baseline evaluation and willing to sign a consent form -Villagers will be eligible to participate in surveys if they slept in a household in cluster randomized to control or focal mass drug administration (fMDA) for at least one night in the past four weeks 6. Eligibility for fMDA - High-risk villagers are defined as 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) will be eligible to receive fMDA that cycle ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Cluster eligibility * Within 8 hours transport of Iquitos * Incidence \<250/1000 and \>2 cases year prior to trial * Population size (\<650) 2. Chloroquine (CQ) eligibility * Resides in neighboring household but within 200 m of Pv index case in the past 2 years * Age ≥6 months old * Present for intervention * Adult ≥18 years old that provides informed consent * A child ≥8 years and \<18 years old that provides informed assent and has informed consent from their parents * A child ≥6 months old and \<8 years old that has informed consent from their parents 3. Tafenoquine (TQ) eligibility * Eligible to receive CQ * Age ≥16 years old * Adult ≥18 years old that provides informed consent * A child ≥16 years and \<18 years old that provides informed assent and has informed consent from their parents 4. Primaquine eligibility * Eligible to receive CQ and ineligible to receive TQ * Age ≥6 months old * Adult ≥18 years old that provides informed consent * A child ≥8 years and \<18 years old that provides informed assent and has informed consent from their parents * A child ≥6 months old and \<8 years old that has informed consent from their parents 5. Baseline evaluation and informed consent -Villagers will be eligible to participate in surveys if they slept in a household in cluster randomized to control or focal mass drug administration (fMDA) for at least one night in the past four weeks 6. Eligibility for fMDA * High-risk villagers are defined as 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) will be eligible to receive fMDA that cycle * Villagers that were eligible but missed in the 1st round in a cycle, or become eligible in the next two months, will not be eligible to receive fMDA in the 2nd round in a cycle. Exclusion Criteria: 1. Chloroquine eligibility * History of retinal or visual field changes * Known hypersensitivity or adverse reaction to CQ * Currently taking CQ or have taken CQ in the past four weeks * Ineligible for TQ or PQ (see criteria below) * Hemoglobin \<9 g/dL 2. Tafenoquine eligibility * G6PD deficiency or intermediate status (defined as activity ≤6.0 UI/gHb per SD biosensor) * G6PD status unknown or refusal of G6PD status test * Acute or severe malaria * Pregnancy (known or identified by pregnancy test) * Refusal of pregnancy test if new amenorrhea in the past 4 weeks * Woman breastfeeding a child that is G6PD deficient or with unknown G6PD status * Known hypersensitivity or adverse reaction to TQ or PQ * Have taken mefloquine (i.e. artesunate- mefloquine), TQ or PQ, or other antimalarial in the past four weeks * Hemoglobin \< 9 g/dL 3. Primaquine eligibility * G6PD deficiency (defined as activity ≤4.0 UI/gHb per SD biosensor) * G6PD status unknown or refusal of G6PD status test * Acute or severe malaria * Pregnancy (known or identified by pregnancy test) * Refusal of pregnancy test if new amenorrhea in the past 4 weeks * Breastfeeding child with documented or unknown G6PD deficiency status * Known hypersensitivity or adverse reaction to TQ or PQ * Have taken mefloquine (i.e. artesunate- mefloquine), TQ or PQ, or other antimalarial in the past four weeks * Hemoglobin \< 9 g/dL

Treatments Being Tested

DRUG

Focal 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)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Asociación Civil Selva Amazónica
Iquitos, Peru

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05690841), the sponsor (University of California, San Francisco), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05690841 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05690841?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05690841?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05690841. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05690841. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.