drugset / Trial / NCT03178643
Enhancing Preventive Therapy of Malaria In Children With Sickle Cell Anemia in East Africa (EPiTOMISE)
Phase 4
Completed
246 enrolled
Duke University
National Heart, Lung, and Blood Institute (NHLBI) · collab
RandomizedParallel-groupOpen-labelPrevention
Summary
This is a randomized, three-arm, open-label, clinical trial of malaria chemoprevention in children with sickle-cell anemia (SCA) at a single site in Homa Bay, Kenya. The study will enroll 246 children under 10 years of age, randomize participants 1:1:1 to one of three malaria chemoprevention regimens, and follow participants monthly for 12 months in order to record clinical episodes of malaria or SCA-related morbidity. Analyses will compare the efficacy of each regimen to prevent malaria and SCA morbidity.
Timeline
- Start
- 2018-01-23
- Primary completion
- 2020-12-16
- Completion
- 2020-12-16
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | ARTENIMOL | Small molecule | 10 mg | — |
| Comparator | ARTENIMOL | Small molecule | 20 mg | — |
| Comparator | ARTENIMOL | Small molecule | 30 mg | — |
| Comparator | ARTENIMOL | Small molecule | 40 mg | — |
| Comparator | ARTENIMOL | Small molecule | 50 mg | — |
| Comparator | ARTENIMOL | Small molecule | 60 mg | — |
| Comparator | Proguanil | Small molecule | 3 mg/kg | Oral |
| Comparator | amodiaquine | Other / unclassified | 153 mg | — |
| Comparator | amodiaquine | Other / unclassified | 229.5 mg | — |
| Comparator | piperaquine | Small molecule | 80 mg | — |
| Comparator | piperaquine | Small molecule | 160 mg | — |
| Comparator | piperaquine | Small molecule | 240 mg | — |
| Comparator | piperaquine | Small molecule | 320 mg | — |
| Comparator | piperaquine | Small molecule | 400 mg | — |
| Comparator | piperaquine | Small molecule | 480 mg | — |
| Comparator | pyrimethamine | Small molecule | 25 mg | — |
| Comparator | pyrimethamine | Small molecule | 37.5 mg | — |
| Comparator | sulfadoxine | Small molecule | 500 mg | — |
| Comparator | sulfadoxine | Small molecule | 750 mg | — |