A Phase 4 interventional study of Cefotaxime and Ceftriaxone in SBP and Liver Cirrhosis, sponsored by Korea University. Completed at 2 sites in Korea, Republic of. Open to participants aged 16 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-04-06.
Sponsored by Korea University · Phase 4, Interventional, and Treatment
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.
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. The expected success rates (infection resolution rates) are 83%, 87%, and 78% for cefotaxime, ceftriaxone, and ciprofloxacin. This is non-inferiority trial. The level of significance is 5%. The power of this stuy is 80%. Non-inferiority margin is 15%. Therefore 87 patients for each group are needed.
1,642 studies on the registry are indexed under Liver Cirrhosis; 358 are open to participants now.
This study's enrollment of 261 is above the median of 72 across 995 interventional studies indexed under Liver Cirrhosis.
Browse Liver Cirrhosis studies →Korea University is the lead sponsor of 64 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
iv 2G q 8hrs for general, dose titration if needed (eg.CKD)
Drug: Cefotaxime
iv 2G q 24hrs
Drug: Ceftriaxone
iv 400mg q 12hrs for general, dose titration if needed (eg.CKD)
Drug: Ciprofloxacin
3 g
2 g
400 mg
Infection resolution rates within 5 days of treatment
PMN \< 250/mm3 from ascitic fluid
Time frame: 5 days (120 hours)
Mortality & recurrence rates within 1 month
Mortality
Time frame: 1 month
This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Korea University