Malaria elimination experiment: entire peruvian villages to receive mass drug dosing
NCT ID NCT05690841
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether giving anti-malarial drugs to everyone in a village can eliminate vivax malaria. Over 7,500 people in Peru will be split into two groups: one receiving standard care (bed nets, screening) and the other also receiving mass drug administration. The goal is to see if this approach reduces new malaria cases over 3 years.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 7,530 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2024
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 * Woman breastfeeding a 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
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Asociación Civil Selva Amazónica
RECRUITINGIquitos, Peru
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Other studies related to the condition(s) this trial covers.
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- Can a pill make your blood deadly to malaria mosquitoes?