Efficacy and Safety of High-dose Ivermectin for Reducing Malaria Transmission: A Dose Finding Study
Status:
Completed
Trial end date:
2016-07-01
Target enrollment:
Participant gender:
Summary
In western Kenya the prevalence of malaria in <5 year olds has fallen from 70% in 1997 to 40%
in 2008, where it has now stagnated. Innovative approaches are needed to continue towards
elimination. Ivermectin is a broad spectrum antiparasitic endectocide widely used for the
control of onchocerciasis and lymphatic filariasis at a dose of 150-200 mcg/kg. Ivermectin at
this dose has a potent, but short-lived effect for 6-11 days on mosquito survival,
egg-laying, and parasite sporogony. Higher doses are needed to prolong its mosquitocidal
effects. Previous studies have shown ivermectin is very well tolerated and safe even up to
2,000 mcg/kg. This dose finding study will evaluate the transmission blocking effect of
high-dose ivermectin to define the optimal dose for future use of ivermectin in combination
with artemisinin-based combination therapy (ACT) for mass drug administration (MDA). It
explores a research question of global relevance. A prolonged transmission blocking effect of
ivermectin could have substantial consequences for malaria control in the next decades. The
results are expected to inform national malaria control programs in malaria endemic
countries, to inform WHO guidelines, and to contribute to the regulatory process.
Phase:
Phase 2
Details
Lead Sponsor:
Liverpool School of Tropical Medicine
Collaborators:
Centers for Disease Control and Prevention Kenya Medical Research Institute