Clinical Trial: Is Spontaneous Bacterial Peritonitis Still Responding to 3rd Generation Cephalosporins?
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Is Spontaneous Bacterial Peritonitis Still Responding to 3rd Generation Cephalosporins?
Brief 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 .
Detailed Summary:
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.
Sponsor: Tanta University
Current Primary Outcome: number of patients with clearence of infection [ Time Frame: 5 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Tanta University
Dates:
Date Received: May 11, 2015
Date Started: January 2015
Date Completion: December 2016
Last Updated: May 9, 2016
Last Verified: May 2016