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

• Status: Not yet recruiting
• Trial end date: 2023-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Oxford
• Collaborators: National Institute for Medical Research, Tanzania; Shanghai Fosun Pharmaceutical Industrial Development Co, Ltd.; University of Kinshasa
• Treatments: Artesunate

Criteria

Inclusion criteria

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.

• Written informed consent by the potential participant

Exclusion criteria

Part 1:

• Participation in other intervention studies

• Known allergy to artemisinin derivatives.

• Known history of parenteral treatment for severe malaria for the current episode of illness before admission. Treatment before admission with an oral antimalarial drug (used for the treatment of uncomplicated malaria) or a single dose of pre-referral rectal artesunate are not exclusion criteria.

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