The results of multicenter trial indicate the antiparasitic drug ivermectin can be safely used in small children, a finding that could expand the scale and impact of campaigns against neglected tropical diseases, an international team of researchers announced today at the annual meeting of the American Society of Tropical Medicine and Hygiene (ASTMH).
Although ivermectin is widely used in mass drug administration campaigns for diseases such as onchocerciasis (river blindness), intestinal worms, and scabies, children under 15 kg (kilograms, or 33 pounds) have been excluded because of limited safety information. The trial investigators said they wanted to revisit the issue following a systematic review and meta-analysis that found the drug was safe in children as small as 11 pounds.
In the double-blinded trial, investigators evaluated the safety, efficacy, and pharmacokinetics of ivermectin in small children by randomly assigning 240 scabies-infected children weighing 11 pounds to less than 33 pounds in The Gambia, Kenya, and Brazil to receive ivermectin treatments at 200, 400, or 800 µg (micrograms) per kg co-administered with placebo cream or placebo tablets with permethrin cream. They then collected venous blood samples on days 0, 3, 7, 10, and 14 for biochemistry, pharmacokinetic, and hematology measurements.
Only one serious adverse event
The results showed that ivermectin was effective against scabies, with only one severe adverse event—a transient liver enzyme increase that returned to baseline levels after 32 days. All other adverse events possibly related to treatment were mild and self-limiting and similar to those observed in people weighing more than 33 pounds.
"Outcomes from the Ivermectin Safety in Small Children trial will hopefully provide greater reassurance that ivermectin can be safely used in children weighing less than 15 kilograms," lead study author Kevin Kobylinski, PhD, a University of Oxford honorary visiting research fellow with the Mahidol Oxford Tropical Medicine Research Unit in Bangkok, said in an ASTMH press release.
"Ivermectin has provided a foundation of some of the most successful interventions in global health, and evidence that it could be safely given to young children could help this work achieve an even greater impact," said ASTMH President David Fidock, PhD.
