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

NCT02831023 Phase 2 COMPLETED

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.

Details

Lead sponsor	University of California, San Francisco
Phase	Phase 2
Status	COMPLETED
Enrolment	80
Start date	2016-07
Completion	2017-01

Conditions

• Malaria

Interventions

• Sulphadoxine-pyrimethamine
• 0.25 mg/kg primaquine
• Dihydroartemisinin-piperaquine
• Methylene blue
• Amodiaquine

Primary outcomes

• Mosquito infectivity assessed through membrane feeding assays — 7 day
  Infectivity will be measured by oocyst prevalence in dissected mosquitoes. Primary endpoint will be a comparison between mean of pretreatment infectivity (day 0) and infectivity at days 2 and 7 post first dose.

Countries

Mali