drugset / Trial / NCT05946642
Innovative Intermittent Preventive Treatment Approaches to Reduce Malaria Burden in School-age Children in Burkina Faso
RandomizedParallel-groupSingle-blindPrevention
Summary
This will be an open label cluster randomized study with two active intervention and one control arm. A cluster will be defined as a selected village. One district implementing seasonal malaria chemoprevention (SMC) will be selected, and six villages will be randomly selected in this district. These six villages will be randomly allocated to each of the three study arms; 1) Arm 1 will receive IPTsc with sulphadoxine-pyrimethamine plus amodiaquine (SPAQ); and 2) Arm 2 will receive dihydroartemisinin-piperaquine (DP) plus Ivermectin (IVM), all given monthly during the transmission season and 3) Control Arm which will have standard malaria control measures including case management and vector control measures as applicable.
Timeline
- Start
- 2023-07-15
- Primary completion
- 2024-05-31
- Completion
- 2024-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ARTENIMOL | Small molecule | 20 mg | Oral |
| Subject | ARTENIMOL | Small molecule | 40 mg | Oral |
| Subject | Ivermectin | Small molecule | 300 ug/kg | Oral |
| Subject | Ivermectin | Small molecule | 400 ug/kg | Oral |
| Subject | Ivermectin | Small molecule | 3 mg | Oral |
| Subject | Ivermectin | Small molecule | 6 mg | Oral |
| Subject | amodiaquine | Other / unclassified | — | — |
| Subject | piperaquine | Small molecule | 160 mg | Oral |
| Subject | piperaquine | Small molecule | 320 mg | Oral |
| Subject | pyrimethamine | Small molecule | — | — |
| Subject | sulfadoxine | Small molecule | — | — |