Effectiveness and Safety of Generic Formulation of Cefoperazone/Sulbactam (Bacticep®) in Treatment of Infections at Siriraj Hospital.

OBJECTIVE: To compare the effectiveness and safety of generic cefoperazone/sulbactam (Bacticep®) and original cefoperazone/ sulbactam (Sulperazon®) in treatment of infections in hospitalized patients at Siriraj Hospital. MATERIAL AND METHOD: Hospitalized patients aged 18 years and older who received cefoperazone/sulbactam for at least 48 hours were identifed 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 cefoperazonel 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.