These results suggest that the safety and efficacy of piperacillin/tazobactam administered every 8 hours are equivalent to those of imipenem/cilastatin administered every 6 hours for the treatment of intra-abdominal infections.
BackgroundComplicated skin and skin structure infections (cSSSIs) frequently result in hospitalization with significant morbidity and mortality.MethodsIn this phase 3b/4 parallel, randomized, open-label, comparative study, 531 subjects with cSSSI received tigecycline (100 mg initial dose, then 50 mg intravenously every 12 hrs) or ampicillin-sulbactam 1.5-3 g IV every 6 hrs or amoxicillin-clavulanate 1.2 g IV every 6-8 hrs. Vancomycin could be added at the discretion of the investigator to the comparator arm if methicillin-resistant Staphylococcus aureus (MRSA) was confirmed or suspected within 72 hrs of enrollment. The primary endpoint was clinical response in the clinically evaluable (CE) population at the test-of-cure (TOC) visit. Microbiologic response and safety were also assessed. The modified intent-to-treat (mITT) population comprised 531 subjects (tigecycline, n = 268; comparator, n = 263) and 405 were clinically evaluable (tigecycline, n = 209; comparator, n = 196).ResultsIn the CE population, 162/209 (77.5%) tigecycline-treated subjects and 152/196 (77.6%) comparator-treated subjects were clinically cured (difference 0.0; 95% confidence interval [CI]: -8.7, 8.6). The eradication rates at the subject level for the microbiologically evaluable (ME) population were 79.2% in the tigecycline treatment group and 76.8% in the comparator treatment group (difference 2.4; 95% CI: -9.6, 14.4) at the TOC assessment. Nausea, vomiting, and diarrhea rates were higher in the tigecycline group.ConclusionsTigecycline was generally safe and effective in the treatment of cSSSIs.Trial registrationClinicalTrials.gov NCT00368537
surgery. MRCP revealed a dilated intrapancreatic CDC remnant with hypointense foci (stones or protein plugs). An ERCP was suggestive of a sludge filled dilated CDC remnant with APBDJ.These patients had undergone a completion distal CBD excision. After the procedure, they have no recurrence of pancreatitis. Conclusion: CDC remnants have persistent reflux of pancreatic juice in remnant CBD due to APBDJ. This result in protein plug/calculi formation in the remnant CBD. This along with a lesser chance of distal CBD getting spontaneously cleared (due to absence of bile flow post CBD excision), predisposes to swelling in the distal CBD, result in recurrent acute pancreatitis.
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