Focal mass drug administration to eliminate Vivax malaria
FocaL Mass Drug Administration for Vivax Malaria Elimination (FLAME): a Pragmatic Cluster Randomized Controlled Trial in Peru
This study is testing whether giving a special malaria treatment to people in certain villages can help reduce the spread of Vivax malaria in Peru.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 7530 (estimated) |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 1 site (Iquitos) |
| Trial ID | NCT05690841 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness of focal mass drug administration (fMDA) in reducing Plasmodium vivax malaria incidence in the Loreto Department of Peru. It is an open-label cluster-randomized controlled trial where villages are randomized to receive either fMDA or standard interventions, including screening and vector control. The fMDA will target high-risk individuals living near previous malaria cases, administering chloroquine and tafenoquine over multiple cycles. The study aims to assess the impact of these interventions on malaria transmission in a low-incidence setting.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 6 months and older living within 200 meters of a previous malaria case in the past two years.
Not a fit: Patients who do not reside in the specified high-risk areas or do not meet the age and health criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of Vivax malaria in targeted communities.
How similar studies have performed: Other studies have shown promise with similar mass drug administration approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Iquitos
- Asociación Civil Selva Amazónica — Iquitos, Peru (Recruiting)
Study contacts
- Principal investigator: Michelle Hsiang, MD — University of California, San Francisco
- Study coordinator: Sydney Fine, MPH
- Email: sydney.fine@ucsf.edu
- Phone: 415-476-5494
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.