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

Primary Bacterial Peritonitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02443285
• Other study ID #: SBP TREATMENT
• Status: Recruiting
• Phase: Phase 3
• First received: May 11, 2015
• Last updated: June 17, 2017
• Start date: January 2015
• Est. completion date: December 2019

Study information

• Verified date: June 2017
• Source: Tanta University
• Contact: Sherief M Abd-elsalam
• Phone: 00201095159522
• Email: Sheriefabdelsalam[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

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 .

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Liver cirrhosis with ascites and SBP

Exclusion Criteria:

• ascitic fluid with polymicrobial infections

Related Conditions & MeSH terms

• Peritonitis
• Primary Bacterial Peritonitis

Intervention

Drug:
• Cefotaxime
Cefotaxime 2 gram every12 hours for 5 days
• ceftriaxone
Ceftriaxone 2 gm every 24 hours for 5 days

Locations

Country	Name	City	State
Egypt	Tanta university - faculty of medicine	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of patients with clearence of infection	number of patients having clearence of infection	5 days