Thompson GR 3rd, Soriano A, Cornely OA, et al; ReSTORE Trial Investigators. Rezafungin versus caspofungin for treatment of candidaemia and invasive candidiasis (ReSTORE): a multicentre, double-blind, double-dummy, randomised phase 3 trial [manuscript published online ahead of print 25 November 2022]. Lancet. https://doi.org/10.1016/S0140-6736(22)02324-8. The ReSTORE investigators reported the results of a multicenter, double-blind, randomized trial comparing treatment of 199 adults with invasive Candida infection, including candidemia, with either rezafungin or caspofungin, each given intravenously. Rezafungin was given weekly with an initial dose of 400 mg followed in subsequent weeks by 200 mg, while 70 mg caspofungin was initially administered followed by 50 mg daily. Two separate primary end-points, aimed at gaining approval by both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), were assessed. The EMA required use of a global endpoint, which consisted of clinical cure, radiological cure, and mycological cure, while the US FDA endpoint was 30-day all-cause mortality. This was a noninferiority trial with a noninferiority margin of 20% in the modified intent-to-treat (mITT) population.
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