Multicenter, double-blind, randomized clinical trial of parenterally administered Cefoselis versus Cefepime for the treatment of acute XXXX .

@entity1 @entity6944 @entity2348 @entity281 @entity1431 @entity1729 @entity293
AIM: This study aims to evaluate the clinical efficacy and safety of intravenous Cefoselis injection for the treatment of acute moderate and severe @entity2348 . @entity1 AND METHODS: A multicenter, double-blind, randomized clinical trial was carried out using Cefepime as control. @entity1 received 1.0 g of either Cefoselis or Cefepime for moderate @entity281 or 2.0 g for severe @entity281 at an interval of 12 hours for 7 to 14 days. A total of 276 @entity1 (138 with Cefoselis, 138 with Cefepime) with @entity1729 were enrolled in the study. Up to 137 and 124 @entity1 receiving Cefoselis and 132 and 125 @entity1 receiving Cefepime were eligible for the ITT (intent to treat) and PP (per protocol) analyses, respectively. RESULTS: At the end of the treatment, the cure rates and effective rates were 59.68% (74/124) and 93.55% (116/124) with Cefoselis, and 56.00% (74/124) and 90.40% (116/124) with Cefepime. The bacterial eradication rates of the two groups were 90.32% and 93.85%, respectively. No statistical differences were observed on the above-mentioned parameters between the two groups (all p > 0.05). Adverse events, mainly mild aminotransferase elevation and mild @entity1431 , were observed in 11.59% (16/138) and 13.77% (19/138) of @entity1 with Cefoselis and @entity6944 , respectively (p > 0.05). CONCLUSIONS: Cefoselis is an effective and safe choice against acute moderate and severe @entity1729 and @entity293 ( @entity293 ).
