drugset / Trial / NCT04864444

Mass Drug Administration of Dihydroartemisinin-piperaquine + Single Low-dose Primaquine to Accelerate Toward Elimination Activities

NCT04864444 ↗

RandomizedParallel-groupOpen-labelPrevention

Summary

This community-based cluster randomized controlled trial aims to evaluate the effectiveness of time-limited, community-wide mass drug administration (MDA) with dihydroartemisinin-piperaquine (DHA-PPQ) and single low-dose primaquine (SLD-PQ) on Plasmodium falciparum transmission compared to standard-of-care seasonal malaria chemoprevention (SMC). The study will be conducted in a moderate-to-low malaria transmission setting of Senegal with optimized malaria control measures (e.g., proactive community case management and piperonyl butoxide pyrethroid long-lasting insecticidal nets (PBO LLINS)).

Timeline

Start
2021-06-19
Primary completion
2022-12-31
Completion
2023-06-30

Outcome

Missed primary endpoint

paper In the post-intervention year (ie, July to December 2022), the adjusted MDA effect was 26% (-17 to 53). PMID 39799956 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject ARTENIMOL Small molecule 160 mg Oral
Subject ARTENIMOL Small molecule 320 mg Oral
Subject Primaquine Small molecule — —
Subject piperaquine Small molecule 20 mg Oral
Subject piperaquine Small molecule 40 mg Oral