drugset / Trial / NCT02831023
Phase 2 Efficacy Study of Primaquine and Methylene Blue
Phase 2
Completed
80 enrolled
University of California, San Francisco
Bill and Melinda Gates Foundation · collabHeidelberg University · collabLondon School of Hygiene and Tropical Medicine · collabMalaria Research and Training Center, Bamako, Mali · collabRadboud University Medical Center · collab
RandomizedParallel-groupSingle-blindTreatment
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.
Timeline
- Start
- 2016-07
- Primary completion
- 2017-01
- Completion
- 2017-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | ARTENIMOL | Small molecule | — | — |
| Subject | Methylene Blue | Diagnostic / imaging agent | 15 mg/kg | — |
| Subject | Primaquine | Small molecule | 0.25 mg/kg | — |
| Subject | amodiaquine | Other / unclassified | — | — |
| Comparator | piperaquine | Small molecule | — | — |
| Subject | pyrimethamine | Small molecule | — | — |
| Subject | sulfadoxine | Small molecule | — | — |