drugset / Trial / NCT01852630

Imipenem Versus Cefepime in Spontaneous Bacterial Peritonitis and to Evaluate the Risk Factors for Treatment Failure

NCT01852630

RandomizedParallel-groupOpen-labelTreatment

Summary

1. All consecutive patients with Cirrhosis and ascites admitted to ILBS (Institute of Liver \& Biliary Sciences) will be evaluated for the presence of SBP (Spontaneous Bacterial Peritonitis) by ascitic fluid examination at admission. 2. SBP (Spontaneous Bacterial Peritonitis) will be diagnosed in the presence of absolute neutrophil count (ANC \>250/mm3) with/without positive ascitic fluid culture and Patients with SBP (Spontaneous Bacterial Peritonitis) included in the study will be randomized to receive cefepime or imipenem. 3. However, other SBP (Spontaneous Bacterial Peritonitis) patients not included for randomization will be given empirical therapy with 3rd generation cephalosporin (ceftriaxone).

Timeline

Start
2012-12
Primary completion
2015-12
Completion
2015-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cefepime Small molecule 1 g Intravenous
Subject IMIPENEM ANHYDROUS Small molecule 1 g Intravenous
Background Albumin Protein / enzyme biologic