Is Spontaneous Bacterial Peritonitis Still Responding to 3rd Generation Cephalosporins?

Study Overview
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Brief Summary
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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 Description
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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.

Official Title
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Is Spontaneous Bacterial Peritonitis Still Responding to 3rd Generation Cephalosporins?

Conditions
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Primary Bacterial Peritonitis

Intervention / Treatment
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* Drug: Cefotaxime
* Drug: ceftriaxone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Liver cirrhosis with ascites and SBP Exclusion Criteria: ascitic fluid with polymicrobial infections
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cefotaxime<br>cefotaxime 2gm every 12 hours daily for 5 days | Drug: Cefotaxime<br>* Cefotaxime 2 gram every12 hours for 5 days<br>* Other names: claforan, cefotax;|
| Active Comparator: Ceftriaxone<br>ceftriaxone 2 gm every 24 hours for 5 days. | Drug: ceftriaxone<br>* Ceftriaxone 2 gm every 24 hours for 5 days<br>* Other names: rocephin, cefaxone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients with clearence of infection | number of patients having clearence of infection | 5 days |