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Last Updated: 02/12/2024
Convenience and cost-aspects of a new 1-STEP reconstitution injectable artesunate compared to conventional 2-STEP injectable artesunate for the treatment of severe falciparum malaria: a multi-centre study (1STEP-AS)
Objectives
This objectives of this project are:
- To assess and compare P. falciparum parasite clearance rates of 1-STEP vs. conventional 2-STEP parenteral artesunate formulations.
- To assess and compare time from intravenous treatment to follow up treatment with oral drugs with 1-STEP vs. conventional 2-STEP parenteral artesunate formulations.
- To assess and compare disease outcome parameters between 1-STEP vs. conventional parenteral artesunate formulations.
- To assess and compare adverse events between 1-STEP vs. conventional 2-STEP parenteral artesunate formulations
Principal Investigators / Focal Persons
Partner Investigators
Lorenz Von Seidlein
Marie Onyamboko
Caterina Fanello
Samwel Gesase
Study Design
This is an individually-randomised controlled non-inferiority trial.
Clinical trial registration number: NCT05140278
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
External reference
Thematic Categories
Date
Jun 2022 — May 2024
Total Project Funding
$214,218
Funding Details
Project Site
Related Resources
