drugset / Trial / NCT04864444
Mass Drug Administration of Dihydroartemisinin-piperaquine + Single Low-dose Primaquine to Accelerate Toward Elimination Activities
Completed
10715 enrolled
University of California, San Francisco
Centers for Disease Control and Prevention · collabL'université de Thiès · collabPopulation Services International · collabProgramme National de Lutte contre le Paludisme, Niger · collabUS President's Malaria Initiative · collab
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
Publications
- Ba EKC, Roh ME, Diallo A, Gadiaga T, Seck A, Thiam S, Fogelson A, Gaye S, Diallo I, Lo AC, Diouf E, Ba OG, Gueye AB, Wu X, Milligan P, Kibuka T, Hama M, Eckert E, Thwing J, Bennett A, Gosling R, Hwang J, Sene D, Ba F, Cisse B, Sturm-Ramirez K, Hsiang MS, Ndiaye JL. Effect of mass drug administration on malaria incidence in southeast Senegal during 2020-22: a two-arm, open-label, cluster-randomised controlled trial. Lancet Infect Dis. 2025 Jun;25(6):656-667. doi: 10.1016/S1473-3099(24)00741-2. Epub 2025 Jan 9.
- Ba Konko Cire EH, Roh ME, Diallo A, Gadiaga T, Seck A, Thiam S, Gaye S, Diallo I, Lo AC, Diouf E, Ba OG, Gueye AB, Fogelson A, Wu X, Milligan P, Kibuka T, Hama M, Eckert E, Thwing J, Bennett A, Gosling R, Hwang J, Sene D, Ba F, Cisse B, Sturm-Ramirez K, Hsiang MS, Ndiaye JL. Mass drug administration to reduce malaria incidence in a low-to-moderate endemic setting: short-term impact results from a cluster randomised controlled trial in Senegal. medRxiv [Preprint]. 2024 Jul 18:2024.07.17.24310593. doi: 10.1101/2024.07.17.24310593.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |