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

NCT05500326 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: 84086
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 5

Brief 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

Keywords

Neglected tropical diseases

Outcome Measures

Primary Outcomes (1)

• Ivermectin drug exposure - Area under the concentration-time curve (AUC0- ∞ )

  ITCHY study: * The mean (standard deviation) of ivermectin exposure as measured by the area under the concentration-time curve (AUC0) in the study population of children aged 2 to \<5 years and weighing 10 to \<15 kg. The calculated AUC will be AUC0- ∞ i.e. from time 0 extrapolated to infinity for a single dose. * Comparable drug exposure will be defined as the mean ivermectin AUC in the study population being ≥80% (efficacy boundary) and ≤125% (toxicity boundary) of the mean AUC in the children aged ≥5 years and weighing ≥15 kg from our previous study with 90% confidence Intervals. ITCHY2 study: -The mean (standard deviation) plasma ivermectin exposure as measured by the area under the concentration-time curve (AUC0-∞) after the first ivermectin dose in the study population of children aged 3 months to 2 years and weighing ≥2 kg. The calculated AUC will be AUC0-∞ i.e. from time 0 extrapolated to infinity for a single dose.

  ITCHY study: 20minutes, 2 hours, 6 hours, 12 hours, 24 hours, 48 hours and 96 hours post-dose. ITCHY2 study: 90mins, 5 hours, 6 hours, 12 hours, 24 hours, 48 hours and 96 hours post dose.

Secondary Outcomes (2)

• Proportion of participants with at least one ivermectin-related adverse event

  Post intervention at Day 14

• The proportion of participants whose scabies infection has improved after treatment with ivermectin

  Day 0 and post-intervention at Day 14

Study Arms (1)

Intervention

EXPERIMENTAL

ITCHY Study: All participants will receive one dose of oral 3mg Ivermectin tablet. ITCHY2 study: Participants will receive one age-specific dose of oral ivermectin tablet. 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

Drug: Ivermectin Tablets

Interventions

Ivermectin Tablets DRUG

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

Intervention

Eligibility Criteria

• Age: 3 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• ITCHY and ITCHY2 study:
• 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

Sponsors & Collaborators

• Murdoch Childrens Research Institute: lead
• Burnet Institute: collaborator
• Lao Tropical and Public Health Institute: collaborator

Study Sites (5)

Banchieng Health Centre

Kasy District, Vientiane Province, Laos

Location

Hinngoon Health Centre

Kasy District, Vientiane Province, Laos

Location

Kasy District Hospital

Kasy District, Vientiane Province, Laos

Location

Poonglack Health Centre

Kasy District, Vientiane, Laos

Location

ThongMeud Health Centre

Kasy District, Vientiane, Laos

Location

Related Publications (1)

• Gwee A, Steer A, Phongluxa K, Luangphaxay C, Senggnam K, Philavanh A, Lei A, Martinez A, Huang S, McWhinney B, Ungerer J, Duffull S, Yang W, Zhu X, Coghlan B. Ivermectin therapy for young children with scabies infection: a multicentre phase 2 non-randomized trial. Lancet Reg Health West Pac. 2024 Jul 13;49:101144. doi: 10.1016/j.lanwpc.2024.101144. eCollection 2024 Aug.

  PMID: 39109221 DERIVED

MeSH Terms

Conditions

Scabies; Pruritus; Neglected Diseases

Interventions

Ivermectin

Condition Hierarchy (Ancestors)

Mite Infestations; Ectoparasitic Infestations; Skin Diseases, Parasitic; Parasitic Diseases; Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Amanda Gwee, PhD

  Murdoch Childrens Research Institute (MCRI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2022
• First Posted: August 15, 2022
• Study Start: June 24, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: 6 months after publication of primary outcome
• Access Criteria: Prior to releasing any data the following are required: a data access agreement must be signed between relevant parties, the ITCHY Trial Principle and Associate Investigators must see and approve the analysis plan describing how the data will be analysed, there must be an agreement around appropriate acknowledgement and any additional costs involved must be covered. Data will only be shared with a recognised research institution which has approved the proposed analysis plan.

Locations

LA (5)