PDF(Pubmed)
Abstract：
UNASSIGNED: Ivermectin, an effective treatment for scabies, is not licensed for children weighing <15 kg. Pharmacokinetic modelling has shown a 3 mg dose in young children (2-4 years, weighing 10-14 kg) achieves comparable drug exposure to a 200 μg/kg dose in children aged ≥5 years. This trial evaluated a 3 mg dose in young children.
UNASSIGNED: Multicentre, phase 2 trial in five health centres in Lao PDR. Children aged 2-4 years, weighing 10-14 kg with scabies received 3 mg ivermectin and had two plasma concentrations determined (Clinicaltrials.gov ID NCT05500326). On day 14, clinical outcomes and adverse effects were assessed, and a second dose given to complete treatment. The primary outcome was the mean plasma ivermectin exposure (AUC0-∞) after the first dose (compared to a historical control of Indigenous Australian children aged ≥5 years weighing ≥15 kg receiving 200 μg/kg). Secondary outcomes were clinical improvement and adverse effects.
UNASSIGNED: Overall, 100 children with a median age of 3.0 years (IQR 2.6-3.9) and weight of 11.9 kg (IQR 11.0-13.1) were enrolled. The mean observed ivermectin AUC0-∞ was comparable to the historical control group aged 5-11 years (815 μg h/L vs 953 μg h/L, p = 0.256). Complete resolution of scabies occurred in 90/99 children by day 14. Adverse effects were mild, occurring in 7/99.
UNASSIGNED: A 3 mg ivermectin dose in children aged 2-4 years and weighing 10-14 kg achieved a mean plasma AUC0-∞ comparable to older children, was highly effective in treating scabies and well tolerated. This study supports extending ivermectin treatment to younger children improving global efforts to control this neglected disease.
UNASSIGNED: Project funding provided by a Thrasher Foundation Early Career Research Award.
UNASSIGNED: Multicentre, phase 2 trial in five health centres in Lao PDR. Children aged 2-4 years, weighing 10-14 kg with scabies received 3 mg ivermectin and had two plasma concentrations determined (Clinicaltrials.gov ID NCT05500326). On day 14, clinical outcomes and adverse effects were assessed, and a second dose given to complete treatment. The primary outcome was the mean plasma ivermectin exposure (AUC0-∞) after the first dose (compared to a historical control of Indigenous Australian children aged ≥5 years weighing ≥15 kg receiving 200 μg/kg). Secondary outcomes were clinical improvement and adverse effects.
UNASSIGNED: Overall, 100 children with a median age of 3.0 years (IQR 2.6-3.9) and weight of 11.9 kg (IQR 11.0-13.1) were enrolled. The mean observed ivermectin AUC0-∞ was comparable to the historical control group aged 5-11 years (815 μg h/L vs 953 μg h/L, p = 0.256). Complete resolution of scabies occurred in 90/99 children by day 14. Adverse effects were mild, occurring in 7/99.
UNASSIGNED: A 3 mg ivermectin dose in children aged 2-4 years and weighing 10-14 kg achieved a mean plasma AUC0-∞ comparable to older children, was highly effective in treating scabies and well tolerated. This study supports extending ivermectin treatment to younger children improving global efforts to control this neglected disease.
UNASSIGNED: Project funding provided by a Thrasher Foundation Early Career Research Award.
摘要：
■伊维菌素，一种有效的治疗疮的方法,体重<15公斤的儿童未获得许可。药代动力学模型显示，幼儿的剂量为3毫克(2-4岁，体重10-14kg）在≥5岁的儿童中达到200μg/kg剂量的可比药物暴露。该试验评估了3mg剂量的幼儿。
■多中心，在老挝人民民主共和国的五个卫生中心进行的第二阶段试验。2-4岁儿童,体重为10-14kg的sc疮患者接受3mg伊维菌素，并测定了两种血浆浓度（Clinicaltrials.govIDNCT05500326）。在第14天，评估临床结果和不良反应，并给予第二剂量以完成治疗。主要结果是首次给药后的平均血浆伊维菌素暴露（AUC0-∞）（与年龄≥5岁，体重≥15kg，接受200μg/kg的澳大利亚土著儿童的历史对照相比）。次要结果是临床改善和不良反应。
■总的来说，纳入100名中位年龄3.0岁（IQR2.6-3.9）、体重11.9kg（IQR11.0-13.1）的儿童。平均观察到的伊维菌素AUC0-∞与5-11岁的历史对照组相当（815μgh/Lvs953μgh/L，p=0.256）。到第14天时，90/99名儿童出现c疮完全消退。副作用轻微,发生在7/99
■3mg伊维菌素剂量用于2-4岁体重10-14kg的儿童，其平均血浆AUC0-∞与年龄较大的儿童相当，在治疗sc疮方面非常有效，并且耐受性良好。这项研究支持将伊维菌素治疗扩展到年幼儿童，以改善控制这种被忽视的疾病的全球努力。
■由Thrasher基金会早期职业研究奖提供的项目资金。
■多中心，在老挝人民民主共和国的五个卫生中心进行的第二阶段试验。2-4岁儿童,体重为10-14kg的sc疮患者接受3mg伊维菌素，并测定了两种血浆浓度（Clinicaltrials.govIDNCT05500326）。在第14天，评估临床结果和不良反应，并给予第二剂量以完成治疗。主要结果是首次给药后的平均血浆伊维菌素暴露（AUC0-∞）（与年龄≥5岁，体重≥15kg，接受200μg/kg的澳大利亚土著儿童的历史对照相比）。次要结果是临床改善和不良反应。
■总的来说，纳入100名中位年龄3.0岁（IQR2.6-3.9）、体重11.9kg（IQR11.0-13.1）的儿童。平均观察到的伊维菌素AUC0-∞与5-11岁的历史对照组相当（815μgh/Lvs953μgh/L，p=0.256）。到第14天时，90/99名儿童出现c疮完全消退。副作用轻微,发生在7/99
■3mg伊维菌素剂量用于2-4岁体重10-14kg的儿童，其平均血浆AUC0-∞与年龄较大的儿童相当，在治疗sc疮方面非常有效，并且耐受性良好。这项研究支持将伊维菌素治疗扩展到年幼儿童，以改善控制这种被忽视的疾病的全球努力。
■由Thrasher基金会早期职业研究奖提供的项目资金。
