Clinical trial NCT05500326: Ivermectin Therapy for Scabies Infection in Children Younger Than 5 Years of Age (ITCHY Study)
Official title: Ivermectin Therapy for Scabies Infection in Children Younger Than 5 Years of Age (ITCHY Study)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Scabies; Itch
Scabies
Keywords: Neglected tropical diseases
Lead sponsor: Murdoch Childrens Research Institute
Sponsor class: OTHER
Collaborators: name: Burnet Institute
name: Lao Tropical and Public Health Institute
First posted: 2022-08-15
Enrollment: 120
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Ivermectin drug exposure - Area under the concentration-time curve (AUC0- ∞ )
timeFrame: 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:
measure: Proportion of participants with at least one ivermectin-related adverse event
timeFrame: Post intervention at Day 14
measure: The proportion of participants whose scabies infection has improved after treatment with ivermectin
timeFrame: Day 0 and post-intervention at Day 14
Other outcomes:
Locations:
city: Kasy District
country: Lao People's Democratic Republic
facility: Banchieng Health Centre
state: Vientiane Province
city: Kasy District
country: Lao People's Democratic Republic
facility: Hinngoon Health Centre
state: Vientiane Province
city: Kasy District
country: Lao People's Democratic Republic
facility: Kasy District Hospital
state: Vientiane Province
city: Kasy district
country: Lao People's Democratic Republic
facility: Poonglack Health Centre
state: Vientiane
city: Kasy District
country: Lao People's Democratic Republic
facility: ThongMeud Health Centre
state: Vientiane
Study officials:
affiliation: Murdoch Childrens Research Institute (MCRI)
name: Amanda Gwee, PhD
role: PRINCIPAL_INVESTIGATOR
References: