Identification of Ascitic Fluid Bacterial Pathogens in Spontaneous Bacterial Peritonitis
NCT ID: NCT02463721
Last Updated: 2018-01-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
100 participants
INTERVENTIONAL
2015-01-31
2019-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Comparative Study of Rifaximin Versus Norfloxacin in the Secondary Prophylaxis of Spontaneous Bacterial Peritonitis
NCT02120196
Comparative Study of Secondary Prophylaxis for SBP
NCT06827756
Rifaximin as a Prophylaxis of Spontaneous Bacterial Peritonitis in Comparison With Ciprofloxacin
NCT06234046
Importance of Peritoneal Free Fluid Cultures in Acute Appendicitis
NCT01953289
Daptomycin + Meropenem Versus Ceftazidime in the Treatment of Nosocomial Spontaneous Bacterial Peritonitis
NCT01455246
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
SBP patients
ascitic fluid culture and microbiological testing for 100 patients with liver cirrhosis and ascites with suspicion of SBP
ascitic fluid culture and microbiological testing
ascitic fluid culture and microbiological testing for 100 patients with liver cirrhosis and ascites with suspicion of SBP
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ascitic fluid culture and microbiological testing
ascitic fluid culture and microbiological testing for 100 patients with liver cirrhosis and ascites with suspicion of SBP
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* ascitic fluid PMNL ≥ 250 cells/mm3
Exclusion Criteria
* patients started empirical antibiotics without prior culture.
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Tanta University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Sherief Abd-Elsalam
PI
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sherief Abd-elsalam, lecturer
Role: PRINCIPAL_INVESTIGATOR
hepatology dept-Tanta
Sally Elnawasany, lecturer
Role: STUDY_CHAIR
hepatology dept-Tanta
WALAA eLKHALAWANY, lecturer
Role: STUDY_CHAIR
hepatology dept-Tanta
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Tanta university hospital
Tanta, , Egypt
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SBP
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.