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

NCT05140278 | Completed Phase 2 DMC

• 1 other identifier: MAL21006
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Parenteral artesunate

Outcome Measures

Primary Outcomes (2)

• Time to administration of treatment comparing 1-step vs. conventional 2-step parenteral artesunate formulations

  Time to administration of treatment comparing 1-step vs. conventional 2-step parenteral artesunate formulations (by time-and-motion methods).

  3 days

• Costs of administration of 1-step vs. conventional 2-step parenteral artesunate formulations

  Costs of administration of 1-step vs. conventional 2-step parenteral artesunate formulations at health facility, and at health system level.

  3 days

Secondary Outcomes (3)

• Implementation perspective assessment of 1-step formulation of parenteral artesunate

  45 minutes

• Practicability assessment of 1-step formulation of parenteral artesunate

  45 minutes

• Satisfaction assessment of 1-step formulation of parenteral artesunate

  45 minutes

Other Outcomes (5)

• Parasite clearance half-life and other parasite clearance parameters compared between 1-step vs. conventional 2-step parenteral artesunate formulations.

  28 days

• Time from start parenteral treatment to follow up treatment with an oral ACT

  28 days

• Fever clearance time

  28 days

Study Arms (2)

1-step Artesunate parenteral arm

EXPERIMENTAL

Argesun (Artesunate 60 mg)

Drug: Argesun 60mg (1 step parenteral artesunate)

2-step Artesunate parenteral arm

EXPERIMENTAL

Artesun (Artesunate 60 mg)

Drug: Artesun 60mg (2-step parenteral artesunate)

Interventions

Argesun 60mg (1 step parenteral artesunate) DRUG

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

1-step Artesunate parenteral arm

Artesun 60mg (2-step parenteral artesunate) DRUG

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.

2-step Artesunate parenteral arm

Eligibility Criteria

• Age: 3 Months - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Part 1:
• Male and female children aged \>3months and \<16 years.
• Clinical diagnosis of severe P. falciparum malaria; or parasitological confirmed P. falciparum hyperparasitaemia \>350,000/ uL.
• Positive malaria test result, by rapid diagnostic test RDT.
• Weight of 5 kg or greater.
• Written informed consent by the parent or guardian.
• Part 2:
• Study staff and health staff
• Study staff who prepare and administer Artesunate injection to patients in the study or health staff who have not administer the Artesunate injection to patients in the study by themselves but are either aware of malaria treatment, Artesunate injection, or have observed the treat-ment provided to severe malaria patients.
• Written informed consent by the study staff and health staff
• Study staff for a short video-record
• Study staff who would like to participate in the video record of a procedure to show how 1-step and 2-step Artesunate injections are prepared and administered.
• Written informed consent by the study staff
• Policymakers and stakeholders
• Those who are working in the National Malaria Control Program (NMCP) or relevant organizations (WHO, INGOs/NGOs) within the country.

You may not qualify if:

• Part 1:
• Participation in other intervention studies
• Known allergy to artemisinin derivatives.
• Part 2:
• Study staff and health staff; Policymakers and stakeholders; Study staff and health staff for a short video-record
• Unwilling to participate in the study
• Unable to communicate

Sponsors & Collaborators

• University of Oxford: lead
• Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.: collaborator
• University of Kinshasa: collaborator
• National Institute for Medical Research, Tanzania: collaborator

Study Sites (1)

KIMORU (KIMORU /ESP Research Center)

Kinshasa, 8502, Democratic Republic of the Congo

Location

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

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

Study Officials

• Caterina Fanello, Ph D

  Kinshasa School of Public Health

  PRINCIPAL INVESTIGATOR

• Samwell Gesase, MD

  Magunga District Hospital

  PRINCIPAL INVESTIGATOR

• Arjen Dondrop, MD

  Mahidol Oxford Tropical Medicine Research Unit Bangkok, Thailand

  PRINCIPAL INVESTIGATOR

• Marie Akatshi Onyamboko

  Kinshasa School of Public Health, University of Kinshasa, DRC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2021
• First Posted: December 1, 2021
• Study Start: July 18, 2022
• Primary Completion: July 29, 2022
• Study Completion: August 11, 2023
• Last Updated: March 15, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)