Effectiveness and Safety of Generic Formulation of
Cefoperazone/Sulbactam (Bacticep®) in Treatment of
Infections at Siriraj Hospital
Pornpan Koomanachai MD*,
Sasima Tongsai PhD**, Visanu Thamlikitkul MD*
Affiliation :
* Division of Infectious Diseases and Tropical Medicine, Department of Medicine, Faculty of Medicine Siriraj Hospital,
Mahidol University, Bangkok, Thailand
** Department of Research and Development, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand
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 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
All Articles
Download