NCT01265173|CompletedPhase 4DMC
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Sponsor study identifier
interventional
261
1 country
2
Study Start
April 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2018
Actual (reported)Study Completion
June 2018
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2007
Date type not reportedThis date has not been verified as actual or estimated.
December 22, 2010
Actual (reported)December 23, 2010
Actual (reported)June 2018
Actual (reported)June 2018
Actual (reported)Infection resolution rates within 5 days of treatment
PMN \< 250/mm3 from ascitic fluid
5 days (120 hours)
Mortality & recurrence rates within 1 month
1 month
iv 2G q 8hrs for general, dose titration if needed (eg.CKD)
iv 2G q 24hrs
iv 400mg q 12hrs for general, dose titration if needed (eg.CKD)
3 g
2 g
Korea University Ansan Hospital
Ansan, South Korea
Korea University Anam Hospital
Seoul, 136705, South Korea
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.
Soon Ho Um, Professor
Korea University
261 participants (actual enrollment reported by the registry).
First Submitted
December 22, 2010
First Posted
December 23, 2010
Study Start
April 2007
Date type not reportedThis date has not been verified as actual or estimated.
Enteral Nutrition in Liver Cirrhosis
Branched Chain Aminoacid Supplementation in Patients With Liver Cirrhosis
400 mg
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
June 2018
Actual (reported)Study Completion
June 2018
Actual (reported)Last Updated
April 6, 2020
Record last verified: 2020-04
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Source: ClinicalTrials.gov.
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