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Ivermectin Therapy for Scabies Infection in Children Younger Than 5 Years of Age (ITCHY Study)
Sponsor: Murdoch Childrens Research Institute
Summary
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.
Key Details
Gender
All
Age Range
3 Months - 5 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2025-06-24
Completion Date
2026-06
Last Updated
2026-03-23
Healthy Volunteers
No
Conditions
Interventions
Ivermectin Tablets
ITCHY Study: All participants will receive one dose of oral ivermectin 3mg on day 0 and have two blood samples taken to determine the serum ivermectin concentrations after the dose. Timing of blood samples will vary depending on the allocated group. ITCHY2 Study: Participants will receive one age-specific dose of oral ivermectin on day 0 and have two blood samples taken to determine the serum ivermectin concentrations after the dose. Timing of blood samples will vary depending on the allocated group. Age specific ivermectin dose: * 0.75mg of ivermectin will be given to participants aged 3 to 7 months * 1.5mg of ivermectin will be given to participants aged 8 to 12 months * 3mg of ivermectin will be given to participants aged 13 to 24 months
Locations (5)
Banchieng Health Centre
Kasy District, Vientiane Province, Laos
Hinngoon Health Centre
Kasy District, Vientiane Province, Laos
Kasy District Hospital
Kasy District, Vientiane Province, Laos
Poonglack Health Centre
Kasy District, Vientiane, Laos
ThongMeud Health Centre
Kasy District, Vientiane, Laos