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
Who is this study for? Patients with Scabies
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 2 months
Maximum Age: 5
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Brazil
Alfredo da Matta Tropical Dermatology Foundation (FUAM)
RECRUITING
Manaus
Gambia
MRC Unit The Gambia
RECRUITING
Banjul
Kenya
Kenya Medical Research Institute
NOT_YET_RECRUITING
Kisumu
Contact Information
Primary
Lorenz von Seidlein, Ass.Prof.
Lorenz@tropmedres.ac
+66-(0)2-3549170
Backup
Kevin Kobylinski, phD
kobylinskikevin@gmail.com
+66-(0)927298013
Time Frame
Start Date: 2023-11-18
Estimated Completion Date: 2024-12
Participants
Target number of participants: 399
Treatments
Active_comparator: Arm 1
Permethrin cream plus placebo tablets
Experimental: Arm 2
Ivermectin (200 µg/kg) plus placebo cream
Experimental: Arm 3
Ivermectin (400 µg/kg) plus placebo cream
Experimental: Arm 4
Ivermectin (800 µg/kg) plus placebo cream (Kenya and The Gambia sites)
Related Therapeutic Areas
Sponsors
Collaborators: Medical Research Center Unit The Gambia (MRCG), Kenya Medical Research Institute, Fundação Alfredo da Matta (FUAM), Fundação de Medicina Tropical Doutor Heitor Vieira Dourado (FMT-HVD)
Leads: University of Oxford