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Clinical Trial Summary

Current European and most other international guidelines recommend the use of a third-generation cephalosporin as the first choice, or amoxicillin-clavulanate acid or fluoroquinolones as an alternative choice .

These recommendations are based mainly on clinical trials that were very often conducted a decade or more ago, and on the assumption that E. coli would be involved in nearly half of the cases.

The microbial etiology of SBP remains relatively constant; however, the antibiotic resistance rate especially for third-generation cephalosporins (including cefotaxime and ceftazidime), ciprofloxacin, and ofloxacin increased dramatically .


Clinical Trial Description

Spontaneous bacterial peritonitis (SBP), defined as an infection of ascites in the absence of a contiguous source of infection.

Spontaneous bacterial peritonitis (SBP) is a common and potentially fatal bacterial infection in patients with cirrhosis and ascites, occurring in 10 to 30% of patients, with in-hospital mortality rates ranging from 20 to 30% .

It is secondary to impaired humoral and cellular immune responses that result in indirect intestinal bacterial translocation into the ascitic fluid .

SBP is also associated with a poor long-term prognosis for patients, as mortality rates can reach 50 to 70% at 1 year .

Early diagnosis and early optimal treatment of these infections with appropriate antibiotics and the prevention of hepatorenal syndrome with albumin are required .

Current European and most other international guidelines recommend the use of a third-generation cephalosporin as the first choice, or amoxicillin-clavulanate acid or fluoroquinolones as an alternative choice.

These recommendations are based mainly on clinical trials that were very often conducted a decade or more ago, and on the assumption that E. coli would be involved in nearly half of the cases.

The microbial etiology of SBP remains relatively constant; however, the antibiotic resistance rate especially for third-generation cephalosporins (including cefotaxime and ceftazidime), ciprofloxacin, and ofloxacin increased dramatically. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02443285
Study type Interventional
Source Tanta University
Contact Sherief M Abd-elsalam
Phone 00201095159522
Email Sheriefabdelsalam@yahoo.com
Status Recruiting
Phase Phase 3
Start date January 2015
Completion date December 2019

See also
  Status Clinical Trial Phase
Recruiting NCT02463721 - Identification of Ascitic Fluid Bacterial Pathogens in Spontaneous Bacterial Peritonitis N/A