drugset / Trial / NCT05081089

Gametocytocidal and Transmission-blocking Efficacy of PQ in Combination With AL and TQ in Combination With SPAQ in Mali

NCT05081089

Phase 2 Completed 80 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 artemether-lumefantrine (AL) with and without a single dose of 0.25mg/kg primaquine (PQ) and sulfadoxine-pyrimethamine with amodiaquine (SPAQ) with and without single dose of 1.66mg/kg tafenoquine (TQ). Outcome measures will include infectivity to mosquitoes at 2, 5 and 7 days after treatment, gametocyte density throughout follow-up, and safety measures including haemoglobin density and the frequency of adverse events.

Timeline

Start
2021-10-12
Primary completion
2021-12-16
Completion
2022-01-13

Drugs

EvaluationDrugModalityDoseRoute
Subject Artemether-lumefantrine Unknown
Subject Primaquine Small molecule 0.25 mg/kg
Subject Tafenoquine Small molecule 1.66 mg/kg
Subject amodiaquine Other / unclassified 150 mg
Subject pyrimethamine Small molecule 25 mg
Subject sulfadoxine Small molecule 500 mg