BridgeMD
New treatment option for Plasmodium Vivax Malaria
Official title FocaL Mass Drug Administration for Vivax Malaria Elimination
ClinicalTrials.gov ID: NCT05690841
What this study is testing
What is Focal Mass Drug Administration (fMDA)?
Focal Mass Drug Administration (fMDA) is an investigational medicine, being studied as a potential treatment for plasmodium vivax malaria.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults. Healthy volunteers may be eligible.
You may be able to join if
- Cluster eligibility
- Within 8 hours transport of Iquitos
- Incidence \ 2 cases year prior to trial
- Population size (\<650)
- Chloroquine (CQ) eligibility
You likely can't join if
- 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
See the full eligibility criteria
- Cluster eligibility
- Within 8 hours transport of Iquitos
- Incidence \ 2 cases year prior to trial
- Population size (\<650)
- 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
- 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
- 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
- Baseline evaluation and informed consent -Villagers will be eligible to participate in surveys if they slept in a household in cluster assigned by chance to control or focal mass drug administration (fMDA) for at least...
- 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)...
- 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.
- 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
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Iquitos, Peru
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Iquitos, Peru. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.