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Clinical Trials/NCT02463721
NCT02463721UnknownNot Applicable

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

Tanta University1 site in 1 country100 target enrollmentStarted: January 1, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
100
Locations
1
Primary Endpoint
identification of SBP bacterial pathogens through gram stain or other specific stains

Study Overview

Brief 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

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 .

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

SBP patients

Other

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

Intervention: ascitic fluid culture and microbiological testing (Other)

Outcomes

Primary Outcomes

identification of SBP bacterial pathogens through gram stain or other specific stains

Time Frame: 6 months

identification of SBP bacterial pathogens through gram stain or other specific stains

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Sherief Abd-Elsalam

PI

Tanta University

Study Sites (1)

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