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

NCT03199755 | Withdrawn Phase 2

• 1 other identifier: 16-297
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Malaria

Keywords

therapeutic; ACT; gametocyte

Outcome Measures

Primary Outcomes (2)

• Change in gametocyte reduction/elimination

  Use microscopy and qPCR to compare change in gametocyte carriage among the 3 treatment arms.

  Day 28 for both microscopic and qPCR measurements.

• Change in parasitemia elimination

  Use microscopy to measure and compare parasitemia elimination in the blood of patients among the 3 treatment arms.

  Day 28 for each patient.

Secondary Outcomes (1)

• Reduced side effects by DLA vs. ACT among the 3 arms

  Through 28 days for each patient.

Study Arms (3)

ACT

ACTIVE COMPARATOR

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

DLA1

EXPERIMENTAL

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

DLA2

EXPERIMENTAL

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

Interventions

ACT DRUG

Current approved drug for treating malaria

Also known as: Coartem, artemether and lumefantrine

ACT

DLA1 DRUG

Experimental drug treatment, single dose.

Also known as: dried leaf artemisia

DLA1

DLA2 DRUG

Experimental drug treatment, doubled the dose of DLA1.

Also known as: dried leaf artemisia

DLA2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Positive RDT for malaria and
• Positive blood smear for malaria.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Worcester Polytechnic Institute: lead
• Plesion International, Coatesville, PA: collaborator
• HEAL Africa Hospital, Goma, Democratic Republic of Congo: collaborator
• Rwanguba Reference Hospital, Rwanguba, Democratic Republic of Congo: collaborator

Study Sites (1)

Rwanguba Reference Hospital

Goma, North Kivu, Democratic Republic of the Congo

Location

MeSH Terms

Conditions

Malaria

Interventions

Artemether, Lumefantrine Drug Combination

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Artemether; Artemisinins; Reactive Oxygen Species; Free Radicals; Inorganic Chemicals; Organic Chemicals; Lumefantrine; Fluorenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sesquiterpenes; Terpenes; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Pamela J Weathers, PhD

  WPI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Biology and Biotechnology

Study Record Dates

• First Submitted: June 22, 2017
• First Posted: June 27, 2017
• Study Start: August 20, 2018
• Primary Completion: December 31, 2018
• Study Completion: October 1, 2019
• Last Updated: October 14, 2021

Record last verified: 2021-10

Locations

DE (1)