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

Study Overview
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Brief Summary
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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.

Detailed Description
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Children aged 2 to <5years and weighing 10 to <15 kg with clinically diagnosed scabies infection in the participating sites in Laos PDR will be approached for recruitment into the study if eligible (see eligibility criteria) and allocated into one of four blood sampling groups with 25 participants in each group. The 3mg dose of ivermectin will be administered orally and blood samples will be collected at two different time points accordingly to blood sampling groups allocation after the first 3mg dose of ivermectin. Clinical responses will be assessed on day 14. A second dose of ivermectin to complete the treatment will only be administered if the first dose has been tolerated by the participants. The 3mg ivermectin drug exposure, safety and effectiveness will be measured.

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

Conditions
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Scabies; Itch, Scabies

Intervention / Treatment
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* Drug: Ivermectin Tablets


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>All participants will received one dose of oral 3mg Ivermectin tablet | Drug: Ivermectin Tablets<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ivermectin drug exposure - Area under the concentration-time curve (AUC0- ∞ ) | 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. | 20minutes, 2 hours, 6 hours, 12 hours, 24 hours, 48 hours and 96 hours post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants with at least one ivermectin-related adverse event | Causality will be assessed using the Naranjo Adverse Drug Reaction Probability Scale Worksheet. The Naranjo Algorithm, or Adverse Drug Reaction Probability Scale, is a method by which to assess whether there is a causal relationship between an identified untoward clinical event and a drug using a questionnaire to assign probability scores. | Post intervention at Day 14 | 
| The proportion of participants whose scabies infection has improved after treatment with ivermectin | The proportion of children whose scabies infection has improved at 14 days as assessed by the same treating clinician as on day 0. The severity of scabies infection will be measured using a descriptive scale (No Change, Improved -Completely resolved, improved-partially resolved, worsened, other, unknown) , the outcome will be presented as descriptive data (i.e percentage of participants in each category of the scale ) | Day 0 and post-intervention at Day 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neglected tropical diseases