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FocaL Mass Drug Administration for Vivax Malaria Elimination

NCT05690841 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 7530

Last updated 2025-11-14

No results posted yet for this study

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.

Conditions

Interventions

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).

Sponsors & Collaborators

  • Universidad Peruana Cayetano Heredia- subcontractor to UCSF as local Sponsor

    collaborator UNKNOWN

  • PATH

    collaborator OTHER

  • Stanford University

    collaborator OTHER

  • Oxford University Clinical Research Unit Indonesia

    collaborator OTHER

  • Menzies School of Health Research

    collaborator OTHER

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • University of California, San Francisco

    lead OTHER

Principal Investigators

  • Michelle Hsiang, MD · University of California, San Francisco

  • Alejandro Llanos-Cuentas, MD, PhD · Universidad Peruana Cayetano Heredia

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-10-14
Primary Completion
2027-05-01
Completion
2027-05-01

Countries

  • Peru

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05690841 on ClinicalTrials.gov