drugset / Trial / NCT01074905

Study on the Treatment of Vivax Malaria

NCT01074905

Phase 3 Completed 655 enrolled University of Oxford Mahidol University · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a randomised open label trial with follow up for 1 year. 660 adults and children above 6 months diagnosed with acute Plasmodium vivax will be randomised into 3 groups, either chloroquine, artesunate, or chloroquine/primaquine therapy. Participants will be screened on the day of inclusion then followed weekly for 8 visits and every 4 weeks until week 52. The primary objective of the study is to compare the efficacy of the WHO and Thai Ministry of Public Health recommended radical curative regimen of chloroquine and primaquine with the currently used monotherapy regimens of chloroquine and artesunate along the Thai-Burmese border.

Timeline

Start
2010-05
Primary completion
2012-10
Completion
2012-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator Artesunate Small molecule 2 mg/kg
Subject Chloroquine Small molecule 25 mg/kg
Subject Primaquine Small molecule 0.5 mg/kg