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

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ClinicalTrials.gov Identifier: NCT03199755
Recruitment Status : Recruiting
First Posted : June 27, 2017
Last Update Posted : October 22, 2018
Sponsor:
Collaborators:
Plesion International, Coatesville, PA
HEAL Africa Hospital, Goma, Democratic Republic of Congo
Rwanguba Reference Hospital, Rwanguba, Democratic Republic of Congo
Information provided by (Responsible Party):
Pamela Weathers, Worcester Polytechnic Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Malaria Drug: ACT Drug: DLA1 Drug: DLA2 Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Dried Leaf Artemisia (DLA) Versus Coartem (ACT): A Randomized Controlled Clinical Trial for Comparing DLA vs. ACT to Treat Malaria
Actual Study Start Date : August 20, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : October 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arm Intervention/treatment
Active Comparator: ACT

Standard Artemisinin Combination Therapy (ACT) being used as currently approved antimalarial therapy at WHO and manufacturer recommended dosage. The specific ACT used is artemether-lumefantrine (Coartem). Form is scored tablets that each contain 20 mg artemether and 120 mg lumefantrine.

Tablets per dose, are given BID for 3 days as shown below:

Coartem tablets/dose by bodyweight; tablets/day morning and evening for total of 6 doses over 3 days

Body weight (kg) and Tablets: 5 to <15 kg, 1 tab; 15 to <25 kg, 2 tabs; 25 to <35 kg, 3 tabs; 35 kg and over, 4 tabs.

Drug: ACT
Current approved drug for treating malaria
Other Names:
  • Coartem
  • artemether and lumefantrine

Experimental: DLA1

Dried leaf Artemisia annua (DLA) from 0.25-1 g total/day, BID. DLA is given as 500 mg tablets according to body weight (see below) for 5 days.

DLA tablets/dose by bodyweight; tablets/day, morning and evening, for total of 10 doses over 5 days.

Body weight (kg) and tablets/dose:

For DLA1x: 5 to < 15 kg, 1/4 tab; 15-30 kg, 1/2 tab; 1/2>30 kg, 1 tab.

Drug: DLA1
Experimental drug treatment, single dose.
Other Name: dried leaf artemisia

Experimental: DLA2

Dried leaf Artemisia annua (DLA) from 0.5-2 g total/day, BID. DLA is given as 500 mg tablets according to body weight (see below) for 5 days.

DLA tablets/dose by bodyweight; tablets/day, morning and evening, for total of 10 doses over 5 days.

Body weight (kg) and tablets/dose:

For DLA2x: 5 to < 15 kg, 1/2 tab; 15-30 kg, 1 tab; >30 kg, 2 tabs.

Drug: DLA2
Experimental drug treatment, doubled the dose of DLA1.
Other Name: dried leaf artemisia




Primary Outcome Measures :
  1. Change in gametocyte reduction/elimination [ Time Frame: Day 28 for both microscopic and qPCR measurements. ]
    Use microscopy and qPCR to compare change in gametocyte carriage among the 3 treatment arms.

  2. Change in parasitemia elimination [ Time Frame: Day 28 for each patient. ]
    Use microscopy to measure and compare parasitemia elimination in the blood of patients among the 3 treatment arms.


Secondary Outcome Measures :
  1. Reduced side effects by DLA vs. ACT among the 3 arms [ Time Frame: Through 28 days for each patient. ]
    Compare patient side effects observationally measured among the 3 treatment arms.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03199755


Contacts
Contact: Pamela J Weathers, PhD 5088315196 weathers@wpi.edu

Locations
Congo, The Democratic Republic of the
Rwanguba Reference Hospital Recruiting
Goma, N Kivu, Congo, The Democratic Republic of the
Contact: Dr. Daddy, MD         
Sponsors and Collaborators
Worcester Polytechnic Institute
Plesion International, Coatesville, PA
HEAL Africa Hospital, Goma, Democratic Republic of Congo
Rwanguba Reference Hospital, Rwanguba, Democratic Republic of Congo
Investigators
Principal Investigator: Pamela J Weathers, PhD WPI

Responsible Party: Pamela Weathers, Professor of Biology and Biotechnology, Worcester Polytechnic Institute
ClinicalTrials.gov Identifier: NCT03199755     History of Changes
Other Study ID Numbers: 16-297
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: October 22, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pamela Weathers, Worcester Polytechnic Institute:
therapeutic
ACT
gametocyte

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Lumefantrine
Artemether
Artemether-lumefantrine combination
Artemisinins
Artemisinine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antifungal Agents
Coccidiostats
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics