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

NCT05500326 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-03-23

No results posted yet for this study

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.

Conditions

  • Scabies; Itch
  • Scabies

Interventions

DRUG

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

Sponsors & Collaborators

  • Burnet Institute

    collaborator OTHER

  • Lao Tropical and Public Health Institute

    collaborator OTHER_GOV

  • Murdoch Childrens Research Institute

    lead OTHER

Principal Investigators

  • Amanda Gwee, PhD · Murdoch Childrens Research Institute (MCRI)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Months
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-24
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • Laos

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05500326 on ClinicalTrials.gov