Phase 2 Efficacy Study of Primaquine and Methylene Blue

Summary

The purpose of this study is to determine the most efficacious transmission blocking drug regimen for seasonal malaria chemoprophylaxis in Mali. The primary outcome measure will be the proportion of mosquitoes infected pre and post-treatment, assessed through membrane feeding and measured by oocyst prevalence in mosquitoes dissected on day 7 post feed. Primary endpoint will be a within group comparison between the mean of the pretreatment infectivity (Day 0) and infectivity at 7 days post first dose.

Conditions

• Malaria

Interventions

DRUG

Sulphadoxine-pyrimethamine

Each Fansidar tablet is scored containing 500mg sulphadoxine and 25 mg pyrimethamine. Doses will be administered by weight.

DRUG

0.25 mg/kg primaquine

Primaquine will be administered in an aqueous solution according to weight-based dosing.

DRUG

Dihydroartemisinin-piperaquine

160mg/20mg or 320mg/40mg of dihydroartemisinin/piperaquine tablets will be used to administer weight-based doses.

DRUG

Methylene blue

Methylene blue will be given as minitablets in prepackaged sachets according to weight groups.

DRUG

Amodiaquine

Amodiaquine will be administered once daily for 3 days, following weight-based dosing of 150 mg tablets.

Sponsors & Collaborators

• Malaria Research and Training Center, Bamako, Mali

  collaborator OTHER

• Radboud University Medical Center

  collaborator OTHER

• London School of Hygiene and Tropical Medicine

  collaborator OTHER

• Heidelberg University

  collaborator OTHER

• Bill and Melinda Gates Foundation

  collaborator OTHER

• University of California, San Francisco

  lead OTHER

Principal Investigators

• Roland Gosling, MD, PhD · University of California, San Francisco

• Alassane Dicko, MD · Malaria Research and Training Centre

• Teun Bousema, PhD · Radboud University Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

5 Years

Max Age

50 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-07-31

Primary Completion

2017-01-31

Completion

2017-01-31

Countries

• Mali

Study Locations