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Abstract:
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Two large (N = 400/group) double-blind, randomized, placebo-controlled, phase 3 trials were conducted to demonstrate the superiority of ZINPLAVA over placebo in patients with C. difficile infection receiving standard of care antibiotics. In both trials, the primary endpoint, recurrent infection (new episode following initial clinical cure) within 12 weeks was met as the rate of recurrent C. difficile infection was significantly lower with ZINPLAVA than with placebo (Study 1: 17% vs. 28%; P< 0.001; Study 2: 16% vs. 26%; P< 0.001). However, the rates of initial clinical cure favored placebo in Study 1 (83% vs. 77%, one-sided p = 0.032) and ZINPLAVA in Study 2 (83% vs. 78%, one-sided p-value = 0.048). Ad-hoc sensitivity analyses designed, conducted, and interpreted by the statistical team to better understand the data and the impact of clinical cure on the primary endpoint presented at the product’s advisory committee meeting proved to be critical to the product’s approval.
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