drugset / Trial / NCT07389057

Assessing the Feasibility of Combining Dihydroartemisinin Piperaquine and Primaquine for Malaria Mass Drug Administration in High Endemic Communities in the Eastern Region of Ghana

NCT07389057

RandomizedParallel-groupOpen-labelTreatment

Summary

Previous malaria control studies in Ghana have shown that community-wide approaches can substantially reduce malaria infections. In a mass testing, treatment and tracking (MTTT) study, more than 75% of people in target communities were reached, leading to a 24% reduction in asymptomatic malaria after one year. However, rapid diagnostic tests (RDTs) can miss very low-level infections, meaning some infected individuals are not treated and can continue to spread malaria. A pilot malaria mass drug administration (MDA) study using artemether-lumefantrine (AL) in the Eastern Region of Ghana showed a very large reduction (over 95%) in parasite carriage after repeated rounds of treatment. Despite this success, malaria infections later fluctuated, possibly because some parasites remained in mosquitoes and because mature gametocytes-the parasite stage responsible for transmission-are not fully eliminated by standard malaria medicines. To better interrupt malaria transmission, this study will use MDA with dihydroartemisinin-piperaquine (DHAP) combined with a single low dose of primaquine (PQ), which targets these transmission stages. The intervention will be given to the whole community every two months (six times per year) and compared with the current standard malaria control measures. The study will examine whether this approach reduces malaria parasite carriage, whether malaria returns after treatment stops, and whether repeated MDA affects malaria drug resistance markers in the population. This two-year implementation research will generate practical evidence to guide national malaria policy in Ghana and inform the potential use of MDA in other malaria-endemic African countries.

Timeline

Start
2023-11-01
Primary completion
2026-11-30
Completion
2026-11-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator ARTENIMOL Small molecule 20 mg Oral
Comparator ARTENIMOL Small molecule 40 mg Oral
Comparator ARTENIMOL Small molecule 60 mg Oral
Comparator ARTENIMOL Small molecule 80 mg Oral
Comparator ARTENIMOL Small molecule 120 mg Oral
Comparator Primaquine Small molecule 0.25 mg/kg
Comparator piperaquine Small molecule 160 mg Oral
Comparator piperaquine Small molecule 320 mg Oral
Comparator piperaquine Small molecule 480 mg Oral
Comparator piperaquine Small molecule 640 mg Oral
Comparator piperaquine Small molecule 960 mg Oral