Ivermectin Therapy for Scabies Infection in Children Younger Than 5 Years of Age (ITCHY Study)
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 5
- 主要终点
- Ivermectin drug exposure - Area under the concentration-time curve (AUC0- ∞ )
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Intervention
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
干预措施: Ivermectin Tablets (Drug)
结局指标
主要结局
Ivermectin drug exposure - Area under the concentration-time curve (AUC0- ∞ )
时间窗: 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.
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.
次要结局
- 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)