Ivermectin Therapy for Scabies Infection in Children Younger Than 5 Years of Age (ITCHY Study)
This is an open label prospective pharmacokinetic single arm study in Laos PDR. This study will be embedded within a cluster-randomized controlled trial of interventions to address childhood undernutrition (SUANHOAM Trial, ACTRN12620000520932) and involves a collaboration with the Murdoch Children's Research Institute, Burnet institute and Lao Tropical and Public Health Institute. ITCHY Study: The primary objective is to determine in young children aged 2 to \<5 years and weighing 10 to \<15 kg if an ivermectin dose of 3 mg achieves comparable drug exposures to the recommended dose in older children. It aims to provide reliable evidence for a safe and effective dose of ivermectin in young children who are especially vulnerable to scabies infections and the associated secondary complications. ITCHY2 Study: An embedded phase 2 multicentre, open label prospective pharmacokinetic study in Laos PDR of ITCHY Study. The primary objective is to determine the plasma ivermectin drug exposure in children aged 3 months to 2 years and weighing ≥2 kg receiving an age specific ivermectin dose.
• ITCHY study:
• Children aged 2 to \<5 years and weighing 10 to \<15 kg with scabies infection as clinically diagnosed by the treating clinician.
• ITCHY2 study:
• Children aged 3 months to 2 years and weighing ≥2 kg with scabies infection as clinically diagnosed by the treating clinician.