Is Spontaneous Bacterial Peritonitis Still Responding to 3rd Generation Cephalosporins?
1 other identifier
interventional
100
1 country
1
Brief Summary
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. 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 P25-P50 for phase_3
Started Jan 2015
Longer than P75 for phase_3
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 11, 2015
CompletedFirst Posted
Study publicly available on registry
May 13, 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
CompletedJune 20, 2017
June 1, 2017
4.9 years
May 11, 2015
June 17, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
number of patients with clearence of infection
number of patients having clearence of infection
5 days
Study Arms (2)
Cefotaxime
ACTIVE COMPARATORcefotaxime 2gm every 12 hours daily for 5 days
Ceftriaxone
ACTIVE COMPARATORceftriaxone 2 gm every 24 hours for 5 days.
Interventions
Ceftriaxone 2 gm every 24 hours for 5 days
Eligibility Criteria
You may qualify if:
- Liver cirrhosis with ascites and SBP
You may not qualify if:
- ascitic fluid with polymicrobial infections
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tanta Universitylead
Study Sites (1)
Tanta university - faculty of medicine
Cairo, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sherief M Abd-elsalam, lecturer
hepatology dept-Tanta
- STUDY DIRECTOR
Hanan H Soliman, Professor
hepatology dept-Tanta
- STUDY CHAIR
Walaa A Elkhalawany, lecturer
hepatology dept-Tanta
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PI
Study Record Dates
First Submitted
May 11, 2015
First Posted
May 13, 2015
Study Start
January 1, 2015
Primary Completion
December 1, 2019
Study Completion
December 1, 2019
Last Updated
June 20, 2017
Record last verified: 2017-06