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Aspoxicillin versus piperacillin in severe abdominal infections--a comparative phase III study
H Scheinin1, T Havia, E Pekkala
1Department of Surgery, Turku University Central Hospital, Finland.
Abstract:
We compared aspoxicillin, a new broad-spectrum penicillin derivative, with piperacillin in severe abdominal infection. Aspoxicillin 4 g administered tds (n = 52) or piperacillin 4 g qds (n = 53) usually as monotherapy were randomly given to patients suffering from perforated appendicitis, acute cholecystitis, ulcer or colon perforation, or intra-abdominal abscess. Blood, tissue and exudate cultures were obtained when applicable for pathogen identification and susceptibility testing. The efficacy rates were similar in the two study groups. Of the 50 evaluable aspoxicillin patients 45 (90%) were considered as treatment responders compared with 48 patients out of 53 (91%) in the piperacillin group (NS). The 95% confidence interval for the efficacy difference was -12% to +11% thus showing no difference between the two drugs. Both drugs were generally well tolerated and no serious drug-related adverse events were noted. However, five patients died because of their illness and one patient had a fatal myocardial infarction. In conclusion, aspoxicillin 4 g tds was shown to be equal to piperacillin 4 g qds in severe abdominal infections.
Insights
A new antibiotic, aspoxicillin, demonstrated comparable efficacy to piperacillin in treating severe abdominal infections. Both broad-spectrum penicillin derivatives were well-tolerated, offering similar treatment outcomes for patients.
Area of Science:
- Infectious Diseases
- Pharmacology
- Clinical Medicine
Background:
- Severe abdominal infections require effective antibiotic therapy.
- Broad-spectrum penicillin derivatives are crucial for managing polymicrobial infections.
- Comparing novel antibiotics with established treatments is essential for clinical practice.
Purpose of the Study:
- To compare the efficacy and safety of aspoxicillin with piperacillin in patients with severe abdominal infections.
- To evaluate aspoxicillin as a potential alternative to piperacillin for this patient population.
Main Methods:
- A randomized trial comparing aspoxicillin (4 g tds) with piperacillin (4 g qds) in patients with severe abdominal infections.
- Inclusion criteria: perforated appendicitis, acute cholecystitis, ulcer or colon perforation, or intra-abdominal abscess.
- Efficacy assessed by treatment response rates; cultures obtained for pathogen identification and susceptibility testing.
Main Results:
- Similar efficacy rates were observed: 90% treatment response for aspoxicillin (45/50) versus 91% for piperacillin (48/53).
- No statistically significant difference in efficacy between the two drugs (95% CI for difference: -12% to +11%).
- Both antibiotics were generally well-tolerated with no serious drug-related adverse events.
Conclusions:
- Aspoxicillin (4 g tds) is therapeutically equivalent to piperacillin (4 g qds) in treating severe abdominal infections.
- Aspoxicillin represents a viable treatment option for severe abdominal infections.
- Further research may explore aspoxicillin in other infection types.