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 treatmentInfection 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
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