Ivermectin Therapy for Scabies Infection in Children Younger Than 5 Years of Age (ITCHY Study)

• Status: Not yet recruiting
• Trial end date: 2024-03-01
• Target enrollment: 0
• Participant gender: All

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. 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Murdoch Childrens Research Institute
• Collaborators: Burnet Institute; Lao Tropical and Public Health Institute
• Treatments: Ivermectin

Criteria

Inclusion Criteria:

• Children aged 2 to <5 years and weighing 10 to <15 kg with scabies infection as clinically diagnosed by the treating clinician.

Exclusion Criteria:

• Children with known liver disease

• Children with known allergy to ivermectin

• Children with concomitant warfarin use

• Children with known neurological disease

• Children already receiving topical treatment for scabies