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Cefoperazone-sulbactam for treatment of intra-abdominal infections: results from a randomized, parallel group study
Abhijit Chandra1, Puneet Dhar, Satish Dharap
1King George Medical University, Lucknow, India.
Background:
Combinations of a third-generation cephalosporin and metronidazole, with or without an aminoglycoside, often are used for the treatment of intra-abdominal infections in surgical settings. Simpler regimens that preserve an adequate spectrum of coverage, but allow easier administration and have fewer side effects, may be a more desirable option.
Methods:
This randomized, open-label, active comparator study evaluated the effectiveness (non-inferiority hypothesis) of the beta-lactam/beta-lactamase inhibitor combination cefoperazone-sulbactam (2-8 g/day), compared with ceftazidime (2-6 g/day)-amikacin (15 mg/kg/day)-metronidazole (500 mg three times daily) in 154 and 152 subjects, respectively, having intra-abdominal infections. The study was conducted at 17 centers in India.
Results:
Non-inferiority of cefoperazone-sulbactam (91.9%) compared with ceftazidime-amikacin-metronidazole (81.8%) was demonstrated for continued resolution of clinical signs and symptoms at the 30-day follow-up (primary endpoint) with a treatment difference of 10.1% (95% confidence interval 2.1%, 18.1%; pre-defined non-inferiority limit > -12.5%). Superiority of cefoperazone-sulbactam also was demonstrated for this endpoint, with significantly more subjects achieving continued resolution at the 30-day follow-up than in the comparator group (p = 0.015). On microbiologic outcomes, cefoperazone-sulbactam had higher success rates than ceftazidime-amikacin-metronidazole (92.9% vs. 80.0%). The pathogens (202 isolated) isolated most commonly were Escherichia coli (38.6%) and Klebsiella spp. (12.9%). The incidence of treatment-related adverse events was 6.5% and 16.4% in the cefoperazone-sulbactam and ceftazidime-amikacin-metronidazole groups, respectively, with more discontinuations due to treatment-related adverse events in the comparator arm (3.2% vs. 9.9%).
Conclusion:
Empirical cefoperazone-sulbactam monotherapy could be a useful adjunct to surgical intervention for intra-abdominal infections.
Insights
Cefoperazone-sulbactam monotherapy demonstrated non-inferiority and superiority in treating intra-abdominal infections compared to a combination regimen. This simpler option showed better clinical and microbiological outcomes with fewer adverse events.
Area of Science:
- Infectious Diseases
- Clinical Pharmacology
- Surgical Infections
Background:
- Intra-abdominal infections are commonly treated with third-generation cephalosporins combined with metronidazole and sometimes an aminoglycoside.
- Simpler antibiotic regimens with adequate coverage, easier administration, and fewer side effects are desirable for treating intra-abdominal infections.
Purpose of the Study:
- To evaluate the non-inferiority and superiority of cefoperazone-sulbactam compared to ceftazidime-amikacin-metronidazole for intra-abdominal infections.
- To assess clinical and microbiological outcomes, as well as adverse events associated with the two treatment regimens.
Main Methods:
- A randomized, open-label, active comparator study conducted across 17 centers in India.
- 154 subjects received cefoperazone-sulbactam (2-8 g/day), and 152 subjects received ceftazidime (2-6 g/day)-amikacin (15 mg/kg/day)-metronidazole (500 mg TID).
- Effectiveness was measured by continued resolution of clinical signs and symptoms at 30-day follow-up.
Main Results:
- Cefoperazone-sulbactam showed non-inferiority (91.9%) and superiority (p=0.015) over ceftazidime-amikacin-metronidazole (81.8%) for clinical resolution at 30 days.
- Microbiological success rates were higher for cefoperazone-sulbactam (92.9%) versus the comparator (80.0%).
- Treatment-related adverse events were significantly lower with cefoperazone-sulbactam (6.5%) compared to the combination therapy (16.4%).
Conclusions:
- Cefoperazone-sulbactam monotherapy is effective and well-tolerated for intra-abdominal infections.
- Empirical cefoperazone-sulbactam can serve as a valuable adjunct to surgical intervention for intra-abdominal infections.
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