NCT06404333已完成2 期
A Randomized Trial to Assess the Safety, Pharmacokinetics, Acceptability, and Efficacy of Pediatric Oral Ivermectin in Scabies Infected Children Weighing 5 to Less Than 15 Kilograms
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Population pharmacokinetic properties of ivermectin concentrations at escalating doses in children <15 kg
研究概览
简要总结
The EPIC-15 trial will evaluate the safety, pharmacokinetics, acceptability, and efficacy of pediatric ivermectin (CHILD-IVITAB) in scabies infected children weighing 5 to less than 15 kg. This trial will support future efforts to expand the indication of ivermectin treatment to infants weighing 5 to less than 15 kg to treat numerous NTDs, allowing this young age group equitable access to the numerous benefits of pediatric ivermectin therapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Male or female child weighing 5 to <15 kilograms
- •≥3 months old
- •Scabies infestation
- •Available to attend all study visits
- •Parents/guardians/carers able to provide written informed consent
排除标准
- •The participant may not enter the trial if ANY of the following apply:
- •A history of renal or hepatic impairment.
- •Any other significant disease or disorder (e.g. moderate or severe malnutrition) which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
- •Participants who are participating or have participated in another research trial involving an investigational product in the past 12 weeks.
- •Children with Crusted/Norwegian scabies or severe secondary bacterial infections (e.g. sepsis)
- •Children who have taken ivermectin within the last month
- •Children with known allergies to ivermectin or excipients
- •Loa loa infection risk, assessed based on travel history to endemic areas
- •Use of prescription (especially CYP3A4 inhibitors or inducers) or non-prescription drugs (except paracetamol at doses of up to 90 milligrams/kg/day), including vitamins (especially vitamin C), herbal and dietary supplements (including St. John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 times the drug half-life (whichever is longer) prior to the first dose of study medication until the completion of the follow-up procedure, unless in the opinion of investigator, the medication will not interfere with the study procedures or compromise participants safety; the investigator will take advice from the manufacturer representative as necessary.
- •The investigator, health care provider or study staff feel that the participant is not suitable for study participation due to chronic illness, suspected underlying illness, or concerns that the participant will not adhere to follow-up schedule.
- •Being born prematurely.
- •Previously enrolled into this study
研究组 & 干预措施
Ivermectin (400 µg/kg)
Experimental
干预措施: CHILD-IVITAB (Drug)
Ivermectin (200 µg/kg)
Experimental
干预措施: CHILD-IVITAB (Drug)
结局指标
主要结局
Population pharmacokinetic properties of ivermectin concentrations at escalating doses in children <15 kg
时间窗: Days 0, 3, 7, 10, 14
次要结局
- Safety of oral ivermectin measures by pruritus outcomes assessed by a composite score recorded on the diary cards.(Assessments will be performed at planned visits on days 0, 3, 7, 10, 14, and daily via diary cards.)
- Safety of oral ivermectin measures by percentage of children with abnormal biochemistry laboratory value(Assessments will be performed at planned visits on days 0, 3, 7, 10, 14)
- Safety of oral ivermectin measures by percentage of children with abnormal hematology laboratory value(Assessments will be performed at planned visits on days 0, 3, 7, 10, 14)
- Safety of oral ivermectin as measured by percentage of children with abnormal neurological test result.(Assessments will be performed at planned visits on days 0, 3, 7, 10, 14.)
- Acceptability of pediatric oral ivermectin assessed by score of assessment tools called ClinSearch Acceptability Score Test (CAST)(Days 0, 7)
- Efficacy of pediatric oral ivermectin to treat scabies in children <15 kg as measured by scabies lesion counts(Days 0, 7, 14)
研究者
研究点 (1)
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