drugset / Trial / NCT03199755
Dried Leaf Artemisia (DLA) Compared to Artemisinin Combination Therapy (ACT) vs Malaria
Phase 2
Withdrawn
Worcester Polytechnic Institute
HEAL Africa Hospital, Goma, Democratic Republic of Congo · collabPlesion International, Coatesville, PA · collabRwanguba Reference Hospital, Rwanguba, Democratic Republic of Congo · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The overall goal is to validate efficacy and potential superiority of dried leaf Artemisia annua (DLA) vs. artemisinin combination therapy (ACT) to cure malaria and to demonstrate elimination of the transmission stage (gametocytes) of the disease. This is a 3 arm trial in Democratic Republic of Congo covering 600 total adult and pediatric patients. Final validation of infection from dried blood samples will be done at WPI.
Timeline
- Start
- 2018-08-20
- Primary completion
- 2018-12-31
- Completion
- 2019-10-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Artemether | Small molecule | 20 mg | Oral |
| Comparator | Artemether | Small molecule | 40 mg | Oral |
| Comparator | Artemether | Small molecule | 60 mg | Oral |
| Comparator | Artemether | Small molecule | 80 mg | Oral |
| Subject | Dried leaf Artemisia annua | Unknown | 125 mg | Oral |
| Subject | Dried leaf Artemisia annua | Unknown | 250 mg | Oral |
| Subject | Dried leaf Artemisia annua | Unknown | 500 mg | Oral |
| Subject | Dried leaf Artemisia annua | Unknown | 1000 mg | Oral |
| Comparator | lumefantrine | Small molecule | 120 mg | Oral |
| Comparator | lumefantrine | Small molecule | 240 mg | Oral |
| Comparator | lumefantrine | Small molecule | 360 mg | Oral |
| Comparator | lumefantrine | Small molecule | 480 mg | Oral |