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Comparison of Efficacy of Cefotaxime, Ceftriaxone, and Ciprofloxacin for the Treatment of Spontaneous Bacterial Peritonitis in Patients With Liver Cirrhosis

Information source: Korea University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: SBP; Liver Cirrhosis

Intervention: Cefotaxime (Drug); Ceftriaxone (Drug); Ciprofloxacin (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Korea University

Official(s) and/or principal investigator(s):
Soon Ho Um, Professor, Principal Investigator, Affiliation: Korea University

Overall contact:
Soon Ho Um, Professor, Phone: 82-2-920-5019, Email: umsh@korea.ac.kr

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.

Clinical Details

Official title: Comparison of Efficacy of Cefotaxime, Ceftriaxone, and Ciprofloxacin for the Treatment of Spontaneous Bacterial Peritonitis in Patients With Liver Cirrhosis

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Infection resolution rates within 5 days of treatment

Infection resolution rates within 5 days

Secondary outcome: Mortality & recurrence rates within 1 month

Detailed description: 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.

Eligibility

Minimum age: 16 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Liver cirrhosis patients with ascites 2. Ascitic fluid PMN cell count >250/mm3 3. Age: 16~70 years old Exclusion Criteria: 1. Allergic to 3rd generation cephalosporin or quinolone 2. Antibiotics within 2 weeks 3. Open abdominal surgery within 4 weeks 4. Evidence of 2ndary peritonitis, intrabdominal hemorrhage, pancreatitis, Tb peritonitis, or peritoneal carcinomatosis 5. HCC with portal vein thrombosis 6. Pregnant woman 7. HIV positive

Locations and Contacts

Soon Ho Um, Professor, Phone: 82-2-920-5019, Email: umsh@korea.ac.kr

Korea University Ansan Hospital, Ansan, Korea, Republic of; Recruiting
Hyung Joon Yim, Phone: 82-3-412-6565, Email: gudwns21@medimail.co.kr

Korea University Anam Hospital, Seoul 136705, Korea, Republic of; Recruiting
Soon Ho Um, Professor, Phone: 82-2-920-5019, Email: umsh@korea.ac.kr
Yeon Seok Seo, Professor, Phone: 82-2-920-6608, Email: drseo@korea.ac.kr

Additional Information

Starting date: April 2007
Last updated: April 8, 2014

Page last updated: August 23, 2015

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