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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Korea University
Sponsor:
Information provided by (Responsible Party):
Soon Ho Um, Korea University
ClinicalTrials.gov Identifier:
NCT01265173
First received: December 22, 2010
Last updated: April 8, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
SBP
Liver Cirrhosis
Drug: Cefotaxime
Drug: Ceftriaxone
Drug: Ciprofloxacin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Efficacy of Cefotaxime, Ceftriaxone, and Ciprofloxacin for the Treatment of Spontaneous Bacterial Peritonitis in Patients With Liver Cirrhosis

Resource links provided by NLM:


Further study details as provided by Korea University:

Primary Outcome Measures:
  • Infection resolution rates within 5 days of treatment [ Time Frame: 5 days (120 hours) ] [ Designated as safety issue: No ]
    PMN < 250/mm3 from ascitic fluid

  • Infection resolution rates within 5 days [ Time Frame: 5 days (120 hours) ] [ Designated as safety issue: Yes ]
    PMN < 250/mm3 from ascites


Secondary Outcome Measures:
  • Mortality & recurrence rates within 1 month [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    Mortality


Estimated Enrollment: 261
Study Start Date: April 2007
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cefotaxime
standard treatment
Drug: Cefotaxime
3 g
Experimental: Ceftriaxone
Potential better treatment
Drug: Ceftriaxone
2 g
Experimental: Ciprofloxacine Drug: Ciprofloxacin
400 mg

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

Ages Eligible for Study:   16 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01265173

Contacts
Contact: Soon Ho Um, Professor 82-2-920-5019 umsh@korea.ac.kr
Contact: Hyung Joon Yim, Professor 82-31-412-6565 gudwns21@korea.ac.kr

Locations
Korea, Republic of
Korea University Ansan Hospital Recruiting
Ansan, Korea, Republic of
Contact: Hyung Joon Yim    82-3-412-6565    gudwns21@medimail.co.kr   
Korea University Anam Hospital Recruiting
Seoul, Korea, Republic of, 136705
Contact: Soon Ho Um, Professor    82-2-920-5019    umsh@korea.ac.kr   
Contact: Yeon Seok Seo, Professor    82-2-920-6608    drseo@korea.ac.kr   
Sponsors and Collaborators
Korea University
Investigators
Principal Investigator: Soon Ho Um, Professor Korea University
  More Information

No publications provided

Responsible Party: Soon Ho Um, Professor, Korea University
ClinicalTrials.gov Identifier: NCT01265173     History of Changes
Other Study ID Numbers: CCCCSBP
Study First Received: December 22, 2010
Last Updated: April 8, 2014
Health Authority: South Korea: Institutional Review Board

Keywords provided by Korea University:
SBP
liver cirrhosis
antibiotics

Additional relevant MeSH terms:
Liver Cirrhosis
Fibrosis
Peritonitis
Liver Diseases
Digestive System Diseases
Pathologic Processes
Peritoneal Diseases
Cefotaxime
Cefoxitin
Ceftriaxone
Ciprofloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 26, 2014