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
| NCT ID | NCT07389057 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Noguchi Memorial Institute for Medical Research |
| Condition | Malaria Asymptomatic Parasitaemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 9,000 participants |
| Start Date | 2023-11-01 |
| Primary Completion | 2026-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 9,000 participants in total. It began in 2023-11-01 with a primary completion date of 2026-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * must be aged 3 months and above and * be resident in the communities for the period of the study, * completed and signed a consent form from the parent or guardian of children below 18 years * Completed and signed assent for 12-17 years old children. * Completed and signed consent for those from age 18 years and above. Exclusion Criteria: * Pregnant women * individual with a life-threatening illness (excluding malaria) * less than 10Kg body weight (or less than 1 year old) * individuals who had experienced adverse effects related to primaquine or * known to be G6PD deficient .
Contact & Investigator
Ndong Ignatius Cheng, PhD
PRINCIPAL INVESTIGATOR
Noguchi Memorial institute for Medical Research, College of Health Sciences, University of Ghana
Frequently Asked Questions
Who can join the NCT07389057 clinical trial?
This trial is open to participants of all sexes, aged 3 Months or older, studying Malaria Asymptomatic Parasitaemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07389057 currently recruiting?
Yes, NCT07389057 is actively recruiting participants. Contact the research team at Ncheng@noguchi.ug.edu.gh for enrollment information.
Where is the NCT07389057 trial being conducted?
This trial is being conducted at Accra, Ghana.
Who is sponsoring the NCT07389057 clinical trial?
NCT07389057 is sponsored by Noguchi Memorial Institute for Medical Research. The principal investigator is Ndong Ignatius Cheng, PhD at Noguchi Memorial institute for Medical Research, College of Health Sciences, University of Ghana. The trial plans to enroll 9,000 participants.