drugset / Trial / NCT05550909

Gametocytocidal and Transmission-blocking Efficacy of ASAQ and ALAQ With or Without PQ in Mali

NCT05550909

Phase 2 Completed 100 enrolled London School of Hygiene and Tropical Medicine
RandomizedParallel-groupSingle-blindTreatment

Summary

The purpose of this study is to compare the gametocytocidal and transmission reducing activity of artesunate-amodiaquine (ASAQ) and artemether-lumefantrine-amodiaquine (ALAQ) with and without a single dose of 0.25mg/kg primaquine (PQ). Outcome measures will include infectivity to mosquitoes at 2, 7 and 14 days after treatment, gametocyte density throughout follow-up, and safety measures including haemoglobin density and the frequency of adverse events.

Timeline

Start
2022-10-17
Primary completion
2022-12-30
Completion
2023-01-26

Drugs

EvaluationDrugModalityDoseRoute
Subject Artemether Small molecule 20 mg
Subject Artesunate Small molecule 50 mg
Subject Artesunate Small molecule 100 mg
Subject Primaquine Small molecule 0.25 mg/kg
Subject amodiaquine Other / unclassified 135 mg
Subject amodiaquine Other / unclassified 153 mg
Subject amodiaquine Other / unclassified 270 mg
Subject lumefantrine Small molecule 120 mg