Kobylinski KC, et al. Oral ivermectin is safe in children weighing 5 to less than 15 kg — a multicenter trial. Presented at: American Society of Tropical Medicine & Hygiene Annual Meeting; Nov. 9-13, 2025; Toronto.
Children weighing less than 15 kg are excluded from treatment with ivermectin due to a lack of safety data.
Researchers have found that the treatment is safe and effective for these children and that therefore
could be safely included in the future, based on the results of this new study.
Although ivermectin is a widely used treatment in mass drug administration campaigns for neglected tropical diseases, it is limited to children weighing less than 15 kg due to a lack of safety information.
Furthermore, some mass drug administration campaigns need to reach around 70% of the target population to be effective, which is difficult to achieve if these children are excluded.
Several doctors and researchers working on a wide range of neglected tropical diseases have expressed the need to extend the use of ivermectin to children weighing less than 15 kg.
The multicenter study included 240 children infected with scabies from Gambia, Kenya, or Brazil, weighing more than 5 kg but less than 15 kg. Twenty-one children were withdrawn or lost to follow-up. The children were randomly assigned to receive 200 µg/kg, 400 µg/kg, or 800 µg/kg of ivermectin in combination with a placebo cream, or to control groups treated with a permethrin cream and placebo tablets. Blood samples were collected and analyzed on days 0, 3, 7, 10, and 14.
The study showed that both ivermectin and permethrin were effective treatments.
In addition, they determined that ivermectin was well tolerated and free of side effects.
Only one child experienced a serious adverse event with a transient increase in liver enzymes, considered possibly related to treatment. The child was given cloxacillin for a septic abscess on the right foot and was kept under observation for up to 32 days, during which time all liver enzymes returned to normal.
All other adverse events potentially related to treatment were mild and self-limiting. They were also consistent with those observed in subjects weighing more than 15 kg.