A Randomised, Double-blind, Placebo-controlled Trial to Assess the Safety, Pharmacokinetics, and Efficacy of Escalating Doses of Oral Ivermectin in Scabies Infected Children Weighing 5 to Less Than 15 Kilograms
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 3
- 主要终点
- Comparing the occurrence of adverse events between the intervention (ivermectin) and control (permethrin) groups
研究概览
简要总结
This trial will evaluate the safety, pharmacokinetics, and efficacy of ivermectin in scabies infected children weighing 5 to less than 15kg. This will allow future efforts to expand the indication of ivermectin treatment to infants weighing 5 to less than 15kg to treat numerous NTDs, allowing this young age group equitable access to the numerous benefits of ivermectin therapy.
详细描述
Scabies is a skin infestation caused by a mite called Sarcoptes scabiei. Scabies is characterised by a rash and severe itching, which is an allergic reaction to the eggs and feces the females deposit as they tunnel under the skin. Oral ivermectin is a very safe and beneficial drug which has been shown to be highly effective for the treatment of scabies and more than a dozen different neglected tropical diseases (NTDs), many of which are associated with important public health problems. Current label indications for ivermectin prevent use in small children weighing less than 15 kg, due to limited safety data in this group. Many of the NTD treatment options for small children rely on compounds that are less safe and/or efficacious compared to oral ivermectin. Our proposal will establish the safety and pharmacokinetics of escalating doses of ivermectin (200, 400, 800 µg/kg) to treat scabies infected children weighing 5 to less than 15 kg. The safety assessment will provide crucial evidence on the use of ivermectin for numerous diseases in children weighing 5 to less than 15 kg. The information from measuring drug concentrations in the patients will inform the optimal dosing of this drug in small children. Assessment of the efficacy of ivermectin, compared to permethrin cream, for the treatment of scabies in small children can provide an important alternative treatment for this widespread disease. This trial has been funded by the Wellcome Trust (grant reference number: 218524/Z/19/Z).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
This is a double-blind trial so the participants, their parents, guardians or carers, administering clinicians, attending nurses, the central research team, and independent outcome assessors will all be blinded.
入排标准
- 年龄范围
- 2 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
- •≥2 months old
- •Scabies infestation
- •Available to attend all study visits
- •Parents/guardians/carers able to provide 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 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 or topical permethrin cream within the last two weeks
- •Children with known allergies to ivermectin or topical permethrin cream 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 patient safety; the investigator will take advice from the manufacturer representative as necessary.
- •The investigator, health care provider or study staff feel that the patient is not suitable for study participation due to chronic illness, suspected underlying illness, or concerns that the patient will adhere to follow-up schedule.
- •Previously treated in the ISSC study
研究组 & 干预措施
Arm 3
Ivermectin (400 µg/kg) plus placebo cream
干预措施: Placebo cream (Other)
Arm 1
Permethrin cream plus placebo tablets
干预措施: Permethrin Cream (Drug)
Arm 1
Permethrin cream plus placebo tablets
干预措施: Placebo tablet (Other)
Arm 2
Ivermectin (200 µg/kg) plus placebo cream
干预措施: Oral ivermectin (Drug)
Arm 2
Ivermectin (200 µg/kg) plus placebo cream
干预措施: Placebo cream (Other)
Arm 3
Ivermectin (400 µg/kg) plus placebo cream
干预措施: Oral ivermectin (Drug)
Arm 4
Ivermectin (800 µg/kg) plus placebo cream (Kenya and The Gambia sites)
干预措施: Oral ivermectin (Drug)
Arm 4
Ivermectin (800 µg/kg) plus placebo cream (Kenya and The Gambia sites)
干预措施: Placebo cream (Other)
结局指标
主要结局
Comparing the occurrence of adverse events between the intervention (ivermectin) and control (permethrin) groups
时间窗: 15 days
Pruritus will be assessed through physical examination and via diary cards provided to the parents/carers.
次要结局
- Population pharmacokinetic properties of ivermectin at escalating doses(15 days)
- Efficacy of oral ivermectin(15 days)