Cardiac Safety of Repeated Doses of Dihydroartemisinin-Piperaquine for the Use in Mass Treatment Campaigns
Status:
Completed
Trial end date:
2016-02-01
Target enrollment:
Participant gender:
Summary
Mass drug administration with antimalarial treatment is a tool that can potentially reduce or
totally eliminate malaria parasite infections from a population.
Dihydroartemisinin-piperaquine (DHA/PPQ) given monthly for 3 months to the entire population
might be a good candidate for mass drug administration because the long acting PPQ exerts a
long post-treatment prophylactic effect against reinfection and relapse. The use of a
repeated dose of DHA/PPQ could lead to increased PPQ plasma concentrations and increased
cardiotoxicity. However, there is no data on a second course of treatment or on safety of the
drug administered in repeated monthly doses. The proposed project is a clinical trial to
assess the electrocardiographic safety of monthly DHA/PPQ (for 3 days at a time) for 3
months. The investigators aim to assess the safety of the drug to be used monthly in mass
treatment campaigns. Recommendations issued from this study will benefit health authorities
on Lihir-Island by setting the stage for a possible subsequent campaign to completely
eliminate malaria from the whole island. This study could be a crucial step to inform the
feasibility of drug-based strategies for eliminating malaria elsewhere in PNG, other
Melanesian countries and throughout the world.
Phase:
Phase 3
Details
Lead Sponsor:
Lihir Medical Centre
Collaborators:
Barcelona Institute for Global Health Papua New Guinea Institute of Medical Research Walter and Eliza Hall Institute of Medical Research