Diarrhea was defined as unformed stools ≥ 3 times per day on two consecutive days, and CDI was confirmed when toxigenic culture was positive in diarrheal patients, or the toxin assay A&B (VIDAS®C. difficile Toxin A & B; BioMerieux SA, Marcy l’Etoile, France) yielded positive results, and/or pseudomembranes were seen by endoscopy or histology [10 (link)]. Healthcare-associated CDI (HA-CDI) was diagnosed in patients who developed diarrhea at least 72 hour after hospitalization or within two months of their last discharge from hospital [15 (link)].
Clinical cure was defined as resolution of diarrhea within the treatment period. This required conversion to no more than two semi-formed or formed stools per day [15 (link)]. Recurrence was defined as growth of C. difficile with toxin genes, positive toxin assay A&B, or pseudomembranes, with recurrence of symptoms between the end of treatment and 30 days later.
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