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

NCT04009343 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 182

Last updated 2025-12-17

No results posted yet for this study

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.

Conditions

  • Uncomplicated Falciparum Malaria

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.

Sponsors & Collaborators

  • Tropical Diseases Research Centre

    collaborator UNKNOWN

  • Johns Hopkins Bloomberg School of Public Health

    lead OTHER

Principal Investigators

  • William J Moss, MD MPH · Johns Hopkins Bloomberg School of Public Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
59 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-19
Primary Completion
2020-08-24
Completion
2026-12-31

Countries

  • Zambia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04009343 on ClinicalTrials.gov