Study to Compare Feasibility of 1-step Injectable Artesunate vs. Conventional 2-step Injectable A… (NCT05140278) | Clinical Trial Compass
CompletedPhase 2
Study to Compare Feasibility of 1-step Injectable Artesunate vs. Conventional 2-step Injectable Artesunate
Democratic Republic of the Congo200 participantsStarted 2022-07-18
Plain-language 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.
Who can participate
Age range
3 Months – 16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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. Treatmen…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time to administration of treatment comparing 1-step vs. conventional 2-step parenteral artesunate formulations
Timeframe: 3 days
2
Costs of administration of 1-step vs. conventional 2-step parenteral artesunate formulations