drugset / Trial / NCT04844905

Summary

This is a cluster-randomized placebo-controlled clinical trial to evaluate the additive benefit of Ivermectin (IVM) (or Placebo) mass drug administration (MDA) to dihydroartemisinin-piperaquine (DP) MDA for malaria control in a moderate to low malaria-endemic setting as an adjunctive strategy to existing programmatic malaria control measures. The regime of DP and IVM will target both human reservoirs of Plasmodium falciparum and the Anopheles gambiae vector respectively, with the aim of interrupting transmission. The trial will be conducted on the Bijagos Archipelago, where islands (clusters) will be randomised to receive seasonal DP and IVM or DP and Placebo MDA. The primary outcome will be the prevalence of infection with Plasmodium falciparum in all age groups detected by nucleic acid amplification testing during the peak malaria transmission season after two years of intervention.

Timeline

Start
2021-05-03
Primary completion
2023-03
Completion
2023-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Ivermectin Small molecule 300 ug/kg Oral
Subject Ivermectin Small molecule 400 ug/kg Oral
Background Dihydroartemisinin-piperaquine Unknown 160 mg Oral
Background Dihydroartemisinin-piperaquine Unknown 320 mg Oral