The investigators hypothesize that the addition of primaquine (PQ) to both
artemether-lumefantrine (AL) and chloroquine (CQ) for the treatment of Plasmodium vivax
infection will result in decreased chance of relapse by about 60%.
The investigators plan to assess the therapeutic efficacy of AL compared to combined AL + PQ
and CQ compared to combined CQ + PQ against P. vivax infection. They also plan to determine
the number of recurrent vivax episodes in patients receiving PQ compared to those who don't
receive PQ. Patients aged above 1 year with symptomatic malaria presenting to health centers
will be enrolled for treatment with AL, AL+PQ, CQ, or CQ+PQ for P. vivax infection.
Phase 1 of the study will monitor the clinical, parasitological, and hematological parameters
for P. vivax infection over a 42-day follow-up period, which will be used to evaluate drug
efficacy. Phase 2 will continue monthly follow-up of these patients for one year to assess
frequency of recurring vivax infections. Results from this research study will be used to
assist Ethiopia in assessing their current national malaria drug policies.
Phase:
Phase 4
Details
Lead Sponsor:
Centers for Disease Control and Prevention
Collaborators:
Columbia University Ethiopian Health and Nutrition Research Institute Federal Ministry of Health, Ethiopia Federal Minstry of Health of Ethiopia Menzies School of Health Research Oromia Regional Health Bureau, Ethiopia United States Agency for International Development (USAID)