NCT02831023

Phase 2 Efficacy Study of Primaquine and Methylene Blue

Efficacy, Safety, and Pharmacokinetics of Sulphadoxine-pyrimethamine-amodiaquine (SP-AQ), SP-AQ Plus Primaquine, Dihydroartemisinin-piperaquine (DP), DP Plus Methylene Blue for Preventing Transmission of P. Falciparum Gametocytes in Mali

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: Male
• Age: 5 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

Protocol will be shared on request.

Conditions

• Malaria

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-07-01
• Primary completion: 2017-01-01
• Completion: 2017-01-01
• First posted: 2016-07-13
• Last updated: 2017-01-11

Locations

1 site across 1 country: Mali