Dataset Information

Ivermectin therapy for young children with scabies infection: a multicentre phase 2 non-randomized trial.

ABSTRACT:

Background

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.

Methods

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 (AUC_0-∞) 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.

Findings

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 AUC_0-∞ 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.

Interpretation

A 3 mg ivermectin dose in children aged 2-4 years and weighing 10-14 kg achieved a mean plasma AUC_0-∞ 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.

Funding

Project funding provided by a Thrasher Foundation Early Career Research Award.

SUBMITTER: Gwee A

PROVIDER: S-EPMC11301252 | biostudies-literature | 2024 Aug

REPOSITORIES: biostudies-literature

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Publications

Ivermectin therapy for young children with scabies infection: a multicentre phase 2 non-randomized trial.

Gwee Amanda A Steer Andrew A Phongluxa Khampheng K Luangphaxay Chanthaly C Senggnam Khanpaseuth K Philavanh Ammala A Lei Alice A Martinez April A Huang Shan S McWhinney Brett B Ungerer Jacobus J Duffull Stephen S Yang Wenyu W Zhu Xiao X Coghlan Ben B

The Lancet regional health. Western Pacific 20240713

<h4>Background</h4>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.<h4>Methods</h4>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 ...[more]

PMID: 39109221

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Project description:BackgroundScabies is often endemic in tribal communities and difficult to control. We assessed the efficacy of a community-based intervention using mass screening and treatment with oral ivermectin in controlling scabies.Methods/ findingsIn this cluster randomised controlled trial, 12 villages were randomly selected from a cluster of 42 tribal villages in Gadchiroli district. In these villages, trained community health workers (CHWs) conducted mass screening for scabies. The diagnosis was confirmed by a physician. Six villages each were randomly allocated to the intervention and usual care arm (control arm). In the intervention arm (population 1184) CHWs provided directly observed oral ivermectin to scabies cases and their household contacts. In the usual care arm (population 1567) scabies cases were referred to the nearest clinic for topical treatment as per the standard practice. The primary outcome was prevalence of scabies two months after the treatment. Secondary outcomes were prevalence of scabies after twelve months of treatment and prevalence of impetigo after two and twelve months of treatment. Outcomes were measured by the team in a similar way as the baseline. The trial was registered with the clinical trial registry of India, number CTRI/2017/01/007704. In the baseline, 2 months and 12 months assessments 92.4%, 96% and 94% of the eligible individuals were screened in intervention villages and 91.4%, 91.3% and 95% in the usual care villages. The prevalence of scabies in the intervention and usual care arm was 8.4% vs 8.1% at the baseline, 2.8% vs 8.8% at two months [adjusted relative risk (ARR) 0.21, 95% CI 0.11-0.38] and 7.3% vs 14.1% (ARR 0.49, 95% CI 0.25-0.98) at twelve months The prevalence of impetigo in the intervention and usual care arm was 1.7% vs 0.6% at baseline, 0.6% vs 1% at two months (ARR 0.55, 95% CI 0.22-1.37) and 0.3% vs 0.7% at 12 months (ARR 0.42, 95% CI 0.06-2.74). Adverse effects due to ivermectin occurred in 12.1% of patients and were mild.ConclusionsMass screening and treatment in the community with oral ivermectin delivered by the CHWs is superior to mass screening followed by usual care involving referral to clinic for topical treatment in controlling scabies in this tribal community in Gadchiroli.

Dataset Information

Ivermectin therapy for young children with scabies infection: a multicentre phase 2 non-randomized trial.

Background

Methods

Findings

Interpretation

Funding

Publications

Ivermectin therapy for young children with scabies infection: a multicentre phase 2 non-randomized trial.

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