Identification of Ascitic Fluid Bacterial Pathogens in Spontaneous Bacterial Peritonitis

Primary Bacterial Peritonitis Clinical Trial

Official title:

Identification of Ascitic Fluid Bacterial Pathogens in Spontaneous Bacterial Peritonitis in Nile Delta and Its Impact on Clinical Outcome of These Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02463721
• Other study ID #: SBP
• Status: Recruiting
• Phase: N/A
• First received: May 27, 2015
• Last updated: December 30, 2017
• Start date: January 2015
• Est. completion date: December 2019

Study information

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

Clinical Trial Summary

Several studies have pointed out changes in the epidemiology of the causative bacteria in SBP and bacterascites and in their susceptibility to antibiotics. In particular, the development of beta-lactamase enzymes, which confer resistance to clavulanate, or extended spectrum beta-lactamases in Escherichia coli. The potential emergence of enterococci, methicillin-resistant S. aureus, or fluoroquinolone-resistant bacteria, following norfloxacin prophylaxis, is also a cause of concern since they may be associated with a higher risk of therapeutic failure.

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.

Several studies have pointed out changes in the epidemiology of the causative bacteria in SBP and bacterascites and in their susceptibility to antibiotics. In particular, the development of beta-lactamase enzymes, which confer resistance to clavulanate, or extended spectrum beta-lactamases in Escherichia coli.The potential emergence of enterococci, methicillin-resistant S. aureus, or fluoroquinolone-resistant bacteria, following norfloxacin prophylaxis, is also a cause of concern since they may be associated with a higher risk of therapeutic failure.

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 suspected to have SBP.

• ascitic fluid PMNL = 250 cells/mm3

Exclusion Criteria:

• ascitic fluid with polymicrobial infections

• patients started empirical antibiotics without prior culture.

Related Conditions & MeSH terms

• Peritonitis
• Primary Bacterial Peritonitis

Intervention

Other:
• ascitic fluid culture and microbiological testing
ascitic fluid culture and microbiological testing for 100 patients with liver cirrhosis and ascites with suspicion of SBP

Locations

Country	Name	City	State
Egypt	Tanta university hospital	Tanta

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	identification of SBP bacterial pathogens through gram stain or other specific stains	identification of SBP bacterial pathogens through gram stain or other specific stains	6 months