Comparison of Efficacy of Cefotaxime, Ceftriaxone, and Ciprofloxacin for the Treatment of SBP in Patients With LC
1 other identifier
interventional
261
1 country
2
Brief Summary
Spontaneous bacterial peritonitis (SBP) is one of the most serious complications of liver cirrhosis. Mainstay of treatment for SBP is use of proper antibiotics. Although, several antibiotics including cefotaxime, ceftriaxone, or ciprofloxacin are being used, it is unclear which drug is most effective. Our aim of study is to compare the efficacy of the three current antibiotics for the treatment of SBP in patients with liver cirrhosis. The primary hypothesis is that the efficacy of all the antibiotics will not significantly different. This is non-inferiority trial.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Apr 2007
Longer than P75 for phase_4
2 active sites
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
April 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 22, 2010
CompletedFirst Posted
Study publicly available on registry
December 23, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedApril 6, 2020
April 1, 2020
11.2 years
December 22, 2010
April 3, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Infection resolution rates within 5 days of treatment
PMN \< 250/mm3 from ascitic fluid
5 days (120 hours)
Secondary Outcomes (1)
Mortality & recurrence rates within 1 month
1 month
Study Arms (3)
Cefotaxime
ACTIVE COMPARATORiv 2G q 8hrs for general, dose titration if needed (eg.CKD)
Ceftriaxone
EXPERIMENTALiv 2G q 24hrs
Ciprofloxacine
EXPERIMENTALiv 400mg q 12hrs for general, dose titration if needed (eg.CKD)
Interventions
Eligibility Criteria
You may qualify if:
- Liver cirrhosis patients with ascites
- Ascitic fluid PMN cell count \>250/mm3
- Age: 16\~70 years old
You may not qualify if:
- Allergic to 3rd generation cephalosporin or quinolone
- Antibiotics within 2 weeks
- Open abdominal surgery within 4 weeks
- Evidence of 2ndary peritonitis, intrabdominal hemorrhage, pancreatitis, Tb peritonitis, or peritoneal carcinomatosis
- HCC with portal vein thrombosis
- Pregnant woman
- HIV positive
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Korea Universitylead
Study Sites (2)
Korea University Ansan Hospital
Ansan, South Korea
Korea University Anam Hospital
Seoul, 136705, South Korea
Related Publications (1)
Yim HJ, Kim TH, Suh SJ, Yim SY, Jung YK, Seo YS, Kang SH, Kim MY, Baik SK, Kim HS, Kim YS, Park SY, Kim BI, Park JY, Heo J, Sohn JH, Heo NY, Han KH, Um SH. Response-Guided Therapy With Cefotaxime, Ceftriaxone, or Ciprofloxacin for Spontaneous Bacterial Peritonitis: A Randomized Trial: A Validation Study of 2021 AASLD Practice Guidance for SBP. Am J Gastroenterol. 2023 Apr 1;118(4):654-663. doi: 10.14309/ajg.0000000000002126. Epub 2023 Jan 3.
PMID: 36594820DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Soon Ho Um, Professor
Korea University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 22, 2010
First Posted
December 23, 2010
Study Start
April 1, 2007
Primary Completion
June 1, 2018
Study Completion
June 1, 2018
Last Updated
April 6, 2020
Record last verified: 2020-04