Overview

Dried Leaf Artemisia (DLA) Compared to Artemisinin Combination Therapy (ACT) vs Malaria

Status:
Withdrawn
Trial end date:
2019-10-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Worcester Polytechnic Institute
Collaborators:
HEAL Africa Hospital, Goma, Democratic Republic of Congo
Plesion International, Coatesville, PA
Rwanguba Reference Hospital, Rwanguba, Democratic Republic of Congo
Treatments:
Artemether
Artemether-lumefantrine combination
Artemether, Lumefantrine Drug Combination
Artemisinine
Artemisinins
Lumefantrine
Criteria
Inclusion Criteria:

- Positive RDT for malaria and

- Positive blood smear for malaria.

Exclusion Criteria:

- All pregnant mothers less than 12 weeks gestational age.

- Children weighing less than 5 kg.

- Patients who have taken any antimalarial immediately prior to study admission.

- All patients with any form of severe malaria.