drugset / Trial / NCT04332068
Ivermectin Safety in Small Children
Phase 2
Completed
240 enrolled
University of Oxford
Fundação Alfredo da Matta (FUAM) · collabFundação de Medicina Tropical Doutor Heitor Vieira Dourado (FMT-HVD) · collabKenya Medical Research Institute · collabMedical Research Center Unit The Gambia (MRCG) · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
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.
Timeline
- Start
- 2023-11-18
- Primary completion
- 2025-04-04
- Completion
- 2025-04-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ivermectin | Small molecule | 200 ug/kg | Oral |
| Subject | Ivermectin | Small molecule | 400 ug/kg | Oral |
| Subject | Ivermectin | Small molecule | 800 ug/kg | Oral |
| Comparator | Permethrin | Small molecule | 5 % | Topical |