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
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
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
Eligibility
Participation Requirements
Sex: All
Minimum Age: 3 months
Maximum Age: 5
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Brazil
Fundação de Dermatologia Tropical e Venereologia Alfredo da Matta (FUAM)
RECRUITING
Manaus
Contact Information
Primary
Kevin Kobylinski, Dr
kevin@tropmedres.ac
+66-(0)92-729-8013
Backup
Lorenz von Seidlein, Dr
Lorenz@tropmedres.ac
+66-(0)2-3549170
Time Frame
Start Date: 2025-02-25
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 66
Treatments
Experimental: Ivermectin (200 µg/kg)
Experimental: Ivermectin (400 µg/kg)
Related Therapeutic Areas
Sponsors
Collaborators: Fundação de Dermatologia Tropical e Venereologia Alfredo da Matta (FUAM), ClinSearch, Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, University of Basel
Leads: University of Oxford