Study to Compare Feasibility of 1-step Injectable Artesunate vs. Conventional 2-step Injectable Artesunate

Summary

The objectives of this study contains 3 parts: (1) a comparison of 1-step parenteral artesunate (AS) versus conventional 2-step parenteral artesunate in patients with severe malaria to assess the feasibility of administration, parasite and fever clearance times in two countries, (2) a quantification of convenience and costs of the new 1-step artesunate parenteral formulation versus the conventional formulation in a randomised study, (3) A cost analysis of 1-step parenteral artesunate using data from Part 1 \& Part 2. This will assess health facility-level costs, and also health system costs to encompass all costs of a potential change from conventional to 1-step artesunate, including re-training, materials, and drug replacement.

The conventional formulation of injectable artesunate requires a 2-step reconstitution and dilution of the artesunate hemisuccinate powder. A new formulation of injectable artesunate has been developed by Fosun Pharma requiring a simpler 1-step reconstitution. Bioequivalence of the new formulation to the conventional formulation.

For part 1, a total number of participants of this study would be 200 participants, estimated 100 per site will be recruited. For part 2, a total number of 40 semi-structured interviews with study staff, health staff, policy makers, and stake holders; and survey/questionnaires with 150 health staff.

Conditions

• Severe Malaria

Interventions

DRUG

Argesun 60mg (1 step parenteral artesunate)

Each vial of powder contains 60mg artesunate. Each ampoule of 6 ml solvent contains: sodium bicarbonate 8.4mg/ml; arginine 20mg/ml.

DRUG

Artesun 60mg (2-step parenteral artesunate)

Each vial of powder contains 60 mg artesunate. Each ampoule of 1 ml solvent contains 50 mg sodium bicarbonate. Each ampoule of 5 ml diluent contains 45 mg sodium chloride.

Sponsors & Collaborators

• Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.

  collaborator INDUSTRY

• University of Kinshasa

  collaborator OTHER

• National Institute for Medical Research, Tanzania

  collaborator OTHER_GOV

• University of Oxford

  lead OTHER

Principal Investigators

• Caterina Fanello, Ph D · Kinshasa School of Public Health

• Samwell Gesase, MD · Magunga District Hospital

• Arjen Dondrop, MD · Mahidol Oxford Tropical Medicine Research Unit Bangkok, Thailand

• Marie Akatshi Onyamboko · Kinshasa School of Public Health, University of Kinshasa, DRC

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

3 Months

Max Age

16 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-07-18

Primary Completion

2022-07-29

Completion

2023-08-11

Countries

• Democratic Republic of the Congo

Study Locations