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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Soon Ho Um, Korea University
ClinicalTrials.gov Identifier:
NCT01265173
First received: December 22, 2010
Last updated: August 21, 2017
Last verified: August 2017
  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
Intervention Model: Parallel Assignment
Masking: None (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 Soon Ho Um, Korea University:

Primary Outcome Measures:
  • Infection resolution rates within 5 days of treatment [ Time Frame: 5 days (120 hours) ]
    PMN < 250/mm3 from ascitic fluid


Secondary Outcome Measures:
  • Mortality & recurrence rates within 1 month [ Time Frame: 1 month ]
    Mortality


Enrollment: 261
Study Start Date: April 2007
Study Completion Date: June 2016
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cefotaxime
iv 2G q 8hrs for general, dose titration if needed (eg.CKD)
Drug: Cefotaxime
3 g
Experimental: Ceftriaxone
iv 2G q 24hrs
Drug: Ceftriaxone
2 g
Experimental: Ciprofloxacine
iv 400mg q 12hrs for general, dose titration if needed (eg.CKD)
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   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

Locations
Korea, Republic of
Korea University Ansan Hospital
Ansan, Korea, Republic of
Korea University Anam Hospital
Seoul, Korea, Republic of, 136705
Sponsors and Collaborators
Korea University
Investigators
Principal Investigator: Soon Ho Um, Professor Korea University
  More Information

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: August 21, 2017

Keywords provided by Soon Ho Um, Korea University:
SBP
liver cirrhosis
antibiotics

Additional relevant MeSH terms:
Liver Cirrhosis
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
Ciprofloxacin
Ceftriaxone
Cefotaxime
Cefoxitin
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 19, 2017