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

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 Overview

• Status: Unknown
• Conditions: Primary Bacterial Peritonitis
• Intervention / Treatment: Drug: Cefotaxime; Drug: ceftriaxone

Detailed 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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Tanta university - faculty of medicine
    • Contact: Sherief M Abdelsalam, lecturer; Phone Number: 00201095159522; Email: Sheriefabdelsalam@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Liver cirrhosis with ascites and SBP

Exclusion Criteria:

• ascitic fluid with polymicrobial infections

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Tanta University
• Investigators: Principal Investigator: Sherief M Abd-elsalam, lecturer, hepatology dept-Tanta; Study Director: Hanan H Soliman, Professor, hepatology dept-Tanta; Study Chair: Walaa A Elkhalawany, lecturer, hepatology dept-Tanta

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: May 11, 2015
• First Submitted That Met QC Criteria: May 12, 2015
• First Posted (Estimate): May 13, 2015

Study Record Updates

• Last Update Posted (Actual): June 20, 2017
• Last Update Submitted That Met QC Criteria: June 17, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Peritoneal Diseases; Intraabdominal Infections; Peritonitis; Anti-Infective Agents; Anti-Bacterial Agents; Ceftriaxone; Cefotaxime; Cefoxitin
• Other Study ID Numbers: SBP TREATMENT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided