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.
Timeline
- Start
- 2016-07
- Primary completion
- 2017-01
- Completion
- 2017-01
Outcome
Met primary endpoint
paper a larger reduction than was noted with sulfadoxine-pyrimethamine and amodiaquine alone (n=12; -10·2%, IQR -143·9 to 56·6; p<0·0001). PMID 29422384 ↗
paper The dihydroartemisinin-piperaquine plus methylene blue (n=11) group had a median 100% (IQR 100 to 100) within-person reduction in mosquito infectivity on day 2 PMID 29422384 ↗
paper Adding a single dose of 0·25 mg/kg primaquine to sulfadoxine-pyrimethamine and amodiaquine or 3 days of 15 mg/kg per day methylene blue to dihydroartemisinin-piperaquine was highly efficacious for preventing P falciparum transmission. PMID 29422384 ↗
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 | — | — |