MedTrace Logo

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

NCT03199755 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2021-10-14

No results posted yet for this study

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.

Conditions

Interventions

DRUG

ACT

Current approved drug for treating malaria

DRUG

DLA1

Experimental drug treatment, single dose.

DRUG

DLA2

Experimental drug treatment, doubled the dose of DLA1.

Sponsors & Collaborators

  • Plesion International, Coatesville, PA

    collaborator UNKNOWN

  • HEAL Africa Hospital, Goma, Democratic Republic of Congo

    collaborator UNKNOWN

  • Rwanguba Reference Hospital, Rwanguba, Democratic Republic of Congo

    collaborator UNKNOWN

  • Worcester Polytechnic Institute

    lead OTHER

Principal Investigators

  • Pamela J Weathers, PhD · WPI

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-20
Primary Completion
2018-12-31
Completion
2019-10-01

Countries

  • Democratic Republic of the Congo

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03199755 on ClinicalTrials.gov