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Sevuparin in children with severe malaria: a phase I safety and dose-finding trial.
Nature Communications · · Clinical Trial, Phase I · Open access
Chaponda, Gwasupika + more
Abstract ↗AI summary
The abstract is read at the publisher; the summary is JClub's.
The maximum tolerated dose of sevuparin in children with severe malaria is 3 mg/kg given in three infusions.
- Why it matters: High mortality rates in children with severe malaria highlight the need for safe adjunctive treatments; understanding dosing safety is essential for future trials.
- What they did: A Phase I dose-finding trial in Kenyan and Zambian children enrolled 23 participants, using the continual reassessment method to identify dose-limiting toxicity across doses from 1.5 to 6 mg/kg.
- The result: The study determined 3 mg/kg as the maximum tolerated dose, with one death and one serious adverse event judged unrelated to sevuparin, supporting further investigation of this dose.
The findingWhy it mattersWhat they didThe result
- Open access