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Pharmacokinetics and Pharmacodynamics of the Gametocytocidal and Post-treatment Chemoprotective Effects of Antimalarials
Sponsor: Johns Hopkins Bloomberg School of Public Health
Summary
Single-center phase II/III clinical investigation of the pharmacokinetics and pharmacodynamics of artemether-lumefantrine and dihydroartemisinin-piperaquine for gametocyte clearance and post-treatment chemoprotection in Zambian children with uncomplicated falciparum malaria.
Official title: Field Study of the Pharmacokinetics and Pharmacodynamics of Artemisinin-based Combination Therapy for Gametocyte Clearance and Post-treatment Chemoprotection in Zambian Children With Uncomplicated Falciparum Malaria
Key Details
Gender
All
Age Range
6 Months - 59 Months
Study Type
INTERVENTIONAL
Enrollment
182
Start Date
2019-06-19
Completion Date
2026-12
Last Updated
2025-12-17
Healthy Volunteers
No
Conditions
Interventions
Artemether-lumefantrine
Children will receive artemether-lumefantrine (20/120 mg) dosed according to weight (5 to \<15 kg: 1 tablet, 15 to \<25 kg: 2 tablets) at 0, 8, 24, 36, 48 and 60 hours. Medications will be administered according to the manufacturer's instructions.
Dihydroartemisinin-piperaquine
Children will receive dihydroartemisinin-piperaquine (40/320 mg) dosed according to weight (5 to \<8 kg: 1/2 tablet, 8 to \<11 kg: 3/4 tablet, 11 to \<17 kg: 1 tablet, 17 to \<25 kg: 1 1/2 tablets) at 0, 24, and 48 hours. Medications will be administered according to the manufacturer's instructions.
Locations (1)
Tropical Diseases Research Centre
Ndola, Copperbelt, Zambia