Abstract
Ivermectin, an effective treatment for scabies, is not licensed for children weighing <15kg. Pharmacokinetic modelling has shown a 3mg dose in young children (2-4 years, weighing 10-14kg) achieves comparable drug exposure to a 200μg/kg dose in children aged ≥5 years. This trial evaluated a 3mg dose in young children. Multicentre, phase 2 trial in five health centres in Lao PDR. Children aged 2-4 years, weighing 10-14kg with scabies received 3mg ivermectin and had two plasma concentrations determined (Clinicaltrials.gov ID NCT05500326). On day 14, clinical outcomes and adverse effects were assessed, and a second dose given to complete treatment. The primary outcome was the mean plasma ivermectin exposure (AUC0-∞) after the first dose (compared to a historical control of Indigenous Australian children aged ≥5 years weighing ≥15kg receiving 200μg/kg). Secondary outcomes were clinical improvement and adverse effects. Overall, 100 children with a median age of 3.0 years (IQR 2.6-3.9) and weight of 11.9kg (IQR 11.0-13.1) were enrolled. The mean observed ivermectin AUC0-∞ was comparable to the historical control group aged 5-11 years (815μgh/L vs 953μgh/L, p=0.256). Complete resolution of scabies occurred in 90/99 children by day 14. Adverse effects were mild, occurring in 7/99. A 3mg ivermectin dose in children aged 2-4 years and weighing 10-14kg achieved a mean plasma AUC0-∞ comparable to older children, was highly effective in treating scabies and well tolerated. This study supports extending ivermectin treatment to younger children improving global efforts to control this neglected disease. Project funding provided by a Thrasher Foundation Early Career Research Award.
Published Version
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