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

Scabies Clinical Trial

— ITCHY  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05500326
• Other study ID #: 84086
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 2024
• Est. completion date: June 2026

Study information

• Verified date: April 2024
• Source: Murdoch Childrens Research Institute
• Contact: Amanda Gwee, PhD
• Phone: +61393455522
• Email: amanda.gwee[@]rch.org.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

ITCHY study: 100 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. ITCHY2 Study: 120 children aged 3 months to 2 years and weighing ≥2 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 30 participants in each group. An age specific 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 dose of ivermectin. 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 Clinical responses of the participants will be assessed on day 14. A second age specific dose of ivermectin to complete the treatment will only be administered if the first dose has been tolerated by the participants. The ivermectin plasma drug exposure, safety and effectiveness will be measured.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: June 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 5 Years

Eligibility

Inclusion Criteria 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. Exclusion Criteria:

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

Related Conditions & MeSH terms

• Scabies

Intervention

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

Locations

Country	Name	City	State
Lao People's Democratic Republic	Banchieng Health Centre	Kasy District	Vientiane Province
Lao People's Democratic Republic	Hinngoon Health Centre	Kasy District	Vientiane Province
Lao People's Democratic Republic	Kasy District Hospital	Kasy District	Vientiane Province
Lao People's Democratic Republic	Poonglack Health Centre	Kasy District	Vientiane
Lao People's Democratic Republic	ThongMeud Health Centre	Kasy District	Vientiane

Sponsors (3)

Lead Sponsor	Collaborator
Murdoch Childrens Research Institute	Burnet Institute, Lao Tropical and Public Health Institute

Country where clinical trial is conducted

Lao People's Democratic Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ivermectin drug exposure - Area under the concentration-time curve (AUC0- 8 )	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- 8 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 (AUC0-8) 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 AUC0-8 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	Proportion of participants with at least one ivermectin-related adverse event	ITCHY and ITCHY2 study: 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
Secondary	The proportion of participants whose scabies infection has improved after treatment with ivermectin	ITCHY and ITCHY2 study: 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