Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT04009343
PHASE2/PHASE3

Pharmacokinetics and Pharmacodynamics of the Gametocytocidal and Post-treatment Chemoprotective Effects of Antimalarials

Sponsor: Johns Hopkins Bloomberg School of Public Health

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

DRUG

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