Project Details

Early Career

Status: Funded - Open

ITCHY study – Ivermectin Therapy in CHildren Younger than 5 years of age

Amanda Gwee, MBBS, FRACP, DTM&H

Summary

BACKGROUND: Ivermectin is an important drug for the prevention and treatment of neglected tropical diseases, however it is not licensed and is therefore inaccessible to the population most vulnerable to these infections: young children aged <5 years and weighing <15 kg. One of the indications for ivermectin therapy is scabies infection, recognized by the World Health Organization as a neglected disease affecting 200 million children at any one time including up to 30% of children in resource-poor settings. GAP: Ivermectin is not currently licensed in children aged 2 to 4 years and weighing <15 kg because a safe, effective dose of ivermectin for young children has not been clinically validated; this study will address this research gap. HYPOTHESIS: In young children aged 2 to 4 years and weighing <15 kg an ivermectin dose of 3 mg: • achieves comparable drug exposures to the recommended dose in older children (primary hypothesis) • is safe and effective for the treatment of scabies infection (secondary hypotheses) METHODS: This is an open label prospective pharmacokinetic study in Laos PDR embedded within a trial of childhood nutrition in collaboration with the Lao Tropical and Public Health Institute. Overall, 100 children aged 2 to 4 years and weighing <15 kg with scabies infection will be enrolled. RESULTS: Pending. IMPACT: The findings from this study will provide the evidence for a safe and effective dose of ivermectin in young children that will facilitate the licensing of ivermectin in this age group making it accessible to children worldwide. This will have significant global health impact in both the prevention and treatment of neglected tropical diseases as children both act as a reservoir of tropical disease transmission and are also vulnerable to infection. Website Link: A/Professor Amanda Gwee | Murdoch Children's Research Institute (mcri.edu.au) Professor Andrew Steer | Murdoch Children's Research Institute (mcri.edu.au)