Single-step versus conventional injectable artesunate for severe malaria in children: an open label, non-inferiority randomized clinical trial, Democratic Republic of the Congo and United Republic of Tanzania

Résumé fourni par la source

Objective: To determine time and cost differences between one- and two-step injectable artesunate formulations for treatment of severe malaria and compare their safety and treatment outcomes. Methods: We conducted an open-label randomized clinical trial at hospitals in Kinshasa, Democratic Republic of the Congo and Korogwe, United Republic of Tanzania in patients aged 3 months to 16 years with severe malaria. We randomly allocated patients to a new one-step injectable artesunate formulation or the conventional two-step formulation. After discharge, patients were followed for 4 weeks. The main outcomes evaluated were time and cost of administering treatment, and clinical and pharmacodynamic effects. Findings: -value: 0.549). Conclusion: In children with severe malaria, one-step injectable artesunate was quicker and cheaper to administer and had equivalent safety and efficacy compared with the conventional formulation.

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