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Identification of Ascitic Fluid Bacterial Pathogens in Spontaneous Bacterial Peritonitis

Primary Purpose

Primary Bacterial Peritonitis

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
ascitic fluid culture and microbiological testing
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Primary Bacterial Peritonitis focused on measuring sbp, culture

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Tanta university hospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

SBP patients

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 27, 2015
Last Updated
December 30, 2017
Sponsor
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT02463721
Brief Title
Identification of Ascitic Fluid Bacterial Pathogens in Spontaneous Bacterial Peritonitis
Official Title
Identification of Ascitic Fluid Bacterial Pathogens in Spontaneous Bacterial Peritonitis in Nile Delta and Its Impact on Clinical Outcome of These Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 . 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Bacterial Peritonitis
Keywords
sbp, culture

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SBP patients
Arm Type
Other
Arm Description
ascitic fluid culture and microbiological testing for 100 patients with liver cirrhosis and ascites with suspicion of SBP
Intervention Type
Other
Intervention Name(s)
ascitic fluid culture and microbiological testing
Intervention Description
ascitic fluid culture and microbiological testing for 100 patients with liver cirrhosis and ascites with suspicion of SBP
Primary Outcome Measure Information:
Title
identification of SBP bacterial pathogens through gram stain or other specific stains
Description
identification of SBP bacterial pathogens through gram stain or other specific stains
Time Frame
6 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sherief Abd-elsalam, lecturer
Phone
00201095159522
Email
Sheriefabdelsalam@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sherief Abd-elsalam, lecturer
Organizational Affiliation
hepatology dept-Tanta
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sally Elnawasany, lecturer
Organizational Affiliation
hepatology dept-Tanta
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
WALAA eLKHALAWANY, lecturer
Organizational Affiliation
hepatology dept-Tanta
Official's Role
Study Chair
Facility Information:
Facility Name
Tanta university hospital
City
Tanta
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sherief Abd-Elsalam
Phone
00201000040794
Email
Sherif_tropical@yahoo.com

12. IPD Sharing Statement

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Identification of Ascitic Fluid Bacterial Pathogens in Spontaneous Bacterial Peritonitis

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