Multi-center Clinical Study of Early Antibios of Severe Acute Pancreatitis

Pancreatitis,Acute Necrotizing Clinical Trial

Official title: Escalade or Deseacalade Antibiotic Use in Severe Acute Pancreatitis

Status Recruiting

Clinical Trial Summary

Strategy of antibiotic therapy in SAP,De-escalate (cefoperazone+metronidazole) or Escalate (meropenem) therapy,which one is better.

Clinical Trial Description

SAP is a serious and life-threatening disease and requires intensive and aggressive management of multiple organ failure and severe infectious complications that can develop in these patients. The most common cause of death in patients suffering from severe acute pancreatitis (SAP) is the infection of pancreatic necrosis by enteric bacteria with mortality rates of 30% (range 14- 62%),spurring the discussion of whether or not prophylactic antibiotic administration could be a beneficial approach. Pancreatic infections are more often monomicrobial, especially E. coli in the two first weeks (100% and 62.5%) of onset, with a shift from gram-negative to gram-positive as the pancreatitis progressed.

In order to evaluate the benefit of prophylactic antibiotic application, a number of randomized controlled clinical trials have been published over the past 15 years. Since the results were conflicting and most studies were of low methodological quality and/or statistically underpowered, meta-analyses have been performed to assess this important issue. However, their results ranged from absolutely no effect of antibiotic prophylaxis to positive effects regarding mortality, the incidence of infected pancreatic necrosis and the incidence of extra pancreatic infections.

In order to provide reliable evidence of the effect of antibiotherapy strategy in SAP, we performed a prospective randomized multicenter clinical trial. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatitis
• Pancreatitis, Acute Necrotizing
• Pancreatitis,Acute Necrotizing

• NCT number: NCT01992198
• Study type: Interventional
• Source: Ruijin Hospital
• Contact: Erzhen Chen, M.D
• Phone: 86-13901753478
• Status: Recruiting
• Phase: Phase 4
• Start date: July 2012
• Completion date: December 2016