drugset / Trial / NCT01265173

Comparison of Efficacy of Cefotaxime, Ceftriaxone, and Ciprofloxacin for the Treatment of SBP in Patients With LC

NCT01265173 ↗

Phase 4 Completed 261 enrolled Korea University
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2007-04
Primary completion
2018-06
Completion
2018-06

Outcome

Missed primary endpoint

paper The resolution rates at 120 hours, which is the primary endpoint, were 67.8%, 77.0%, and 73.6% in the cefotaxime, ceftriaxone, and ciprofloxacin groups, respectively ( P = 0.388) PMID 36594820 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cefotaxime Small molecule 3 g Intravenous
Subject Ceftriaxone Other / unclassified 2 g Intravenous
Subject Ciprofloxacin Small molecule 400 mg Intravenous

Indications