Identification of Ascitic Fluid Bacterial Pathogens in Spontaneous Bacterial Peritonitis
1 other identifier
interventional
100
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 27, 2015
CompletedFirst Posted
Study publicly available on registry
June 4, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedJanuary 3, 2018
December 1, 2017
4.9 years
May 27, 2015
December 30, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
SBP patients
OTHERascitic fluid culture and microbiological testing for 100 patients with liver cirrhosis and ascites with suspicion of SBP
Interventions
ascitic fluid culture and microbiological testing for 100 patients with liver cirrhosis and ascites with suspicion of SBP
Eligibility Criteria
You may qualify if:
- Liver cirrhosis with ascites and suspected to have SBP.
- ascitic fluid PMNL ≥ 250 cells/mm3
You may not qualify if:
- ascitic fluid with polymicrobial infections
- patients started empirical antibiotics without prior culture.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tanta Universitylead
Study Sites (1)
Tanta university hospital
Tanta, Egypt
Study Officials
- PRINCIPAL INVESTIGATOR
Sherief Abd-elsalam, lecturer
hepatology dept-Tanta
- STUDY CHAIR
Sally Elnawasany, lecturer
hepatology dept-Tanta
- STUDY CHAIR
WALAA eLKHALAWANY, lecturer
hepatology dept-Tanta
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PI
Study Record Dates
First Submitted
May 27, 2015
First Posted
June 4, 2015
Study Start
January 1, 2015
Primary Completion
December 1, 2019
Study Completion
December 1, 2019
Last Updated
January 3, 2018
Record last verified: 2017-12