Material and Method: Hospitalized patients aged 18 years and older who received cefoperazone/sulbactam for at least 48 hours were identified from the Siriraj Hospital pharmacy database. Medical records of identified patients were reviewed and relevant information was extracted and transferred onto pre-printed case record forms. Patient data relating to demographics, clinical features of infections, antibiotic therapy, and treatment outcomes were evaluated and compared between patients who received generic and original cefoperazone/sulbactam.

Results: Two hundred twenty nine hospitalized patients who had infections and received original or generic cefoperazone/sulbactam were included. Baseline characteristics and clinical features of infections in both groups were comparable. Favorable outcomes (72.9% vs. 72.2%, p = 1.00) and infection-related deaths (4.7% vs. 11.1%, p = 0.16) between generic cefoperazone/sulbactam group and original cefoperazone/sulbactam group, respectively, were not significantly different. Generic cefoperazone/sulbactam favorable outcomes were found to be non-inferior to original cefoperazone/sulbactam (p = 0.04), with lower bound of one-sided 95% CI for difference in favorable outcome within the pre-specified non-inferiority margin of -10% (95% CI: 0.7% with lower bound of -9.3). No significant differences in adverse events were observed between groups.

Conclusion: Generic cefoperazone/sulbactam (Bacticep®) was found to be non-inferior to original cefoperazone/sulbactam for therapy of infections in hospitalized patients at Siriraj Hospital.

Keywords: Cefoperazone/sulbactam, Effectiveness, generic, Non-inferiority, Original, Safety