Health TrialsbyHealthPanel

FocaL Mass Drug Administration for Vivax Malaria Elimination

ConditionsPlasmodium Vivax MalariaMalaria
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversity of California, San Francisco

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Cluster eligibility

Within 8 hours transport of Iquitos

Incidence <250/1000 and >2 cases year prior to trial

Population size (<650)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Focal Mass Drug Administration (fMDA)

    Drug

    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).

Treatment groups

7,530 Participants
are divided into 2 treatment groups
Group A: Control: Standard InterventionsNo intervention 0 interventions
Group B: Focal Mass Drug Administration (fMDA)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Cumulative Incidence of Plasmodium vivax infections

Number of microscopy-confirmed, Plasmodium vivax malaria cases in residents reported from health facilities per population over the 36-month follow-up study period

Time frame
From enrollment through study completion, over 36-month follow-up study period

Secondary outcomes

1

Prevalence of Plasmodium vivax infection

Proportion of individuals with polymerase chain reaction (PCR)-confirmed infection in an endline survey

Time frame
At endline survey in trial year 4, 3 years after enrollment in study in trial year 1
2

Plasmodium vivax seroprevalence

Proportion of participants who are seropositive, rate at which seronegative individuals became seropositive estimated from age-specific seroprevalence from endline survey, adjusted by modeling longitudinal individual serological status and/or antibody titers

Time frame
At endline survey in trial year 4, 3 years after enrollment in study in trial year 1
3

Genetic diversity of Plasmodium vivax

Diversity of locally acquired infections as defined by sequencing results

Time frame
From enrollment through study completion, over 4 trial years
4

Tolerability of study drugs

Vomiting following administration of study drugs and non-adherence related to adverse effects

Time frame
Over drug administration period, unique for each study drug (7 days for CQ/PQ regimens and 3 days for CQ/TQ regimens)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, San Francisco

Lead sponsor

Universidad Peruana Cayetano Heredia

Collaborator

PATH

Collaborator

Stanford University

Collaborator

Oxford University Clinical Research Unit Indonesia

Collaborator

Menzies School of Health Research

Collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

GlaxoSmithKline

Collaborator

Medicines for Malaria Venture

Collaborator

Source ClinicalTrials.gov
Apply now