| Autor: |
Mainga Hamaluba, Thomas N. Williams, Christabel Mogoka, Luc Kambale Kamavu, Mike Chaponda, Sam Miti, Nick White, Nick Day, Nchafatso Obonyo, Diana M. Gibb, Elizabeth C. George, Arjen Dondorp, Kathryn Maitland, Roisin Connon, A. Sarah Walker, Emmanuel Oguda |
| Jazyk: |
angličtina |
| Rok vydání: |
2023 |
| Předmět: |
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| Zdroj: |
Wellcome Open Research, Vol 8 (2023) |
| Druh dokumentu: |
article |
| ISSN: |
2398-502X |
| DOI: |
10.12688/wellcomeopenres.20111.1 |
| Popis: |
Background Even on the best antimalarial treatments (injectable artesunate) African children with severe malaria have poor outcomes with most deaths occurring early in the course of hospital admission ( 2mmol/l). Three intravenous doses will be given at admission (0 hours), 8 and 16 hours. APPT will be measured 1 hour after each dose (to assess maximum toxicity). Studying 20 children will allow sufficient data on safety to be generated across a range of doses to identify the maximum tolerated dose (MTD) using the Continual Reassessment Method, which adapts or informs subsequent doses for each child based on the data from previously enrolled children. The MTD will be identified based on the dose-toxicity model updated by each previous patient’s APTT results using standard methods. Conclusions The results of the Phase I trial will identify the final dose to be tested in a Phase II trial in terms of both efficacy and safety outcomes. Registration PACTR number: 202007890194806 (date 20/07/2020) ISRCTN32271864 (date 28/07/2021) |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
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