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

Primary Purpose

SBP, Liver Cirrhosis

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Cefotaxime
Ceftriaxone
Ciprofloxacin
Sponsored by
Korea University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for SBP focused on measuring SBP, liver cirrhosis, antibiotics

Eligibility Criteria

16 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Korea University Ansan Hospital
  • Korea University Anam Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Cefotaxime

Ceftriaxone

Ciprofloxacine

Arm Description

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)

Outcomes

Primary Outcome Measures

Infection resolution rates within 5 days of treatment
PMN < 250/mm3 from ascitic fluid

Secondary Outcome Measures

Mortality & recurrence rates within 1 month
Mortality

Full Information

First Posted
December 22, 2010
Last Updated
April 3, 2020
Sponsor
Korea University
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1. Study Identification

Unique Protocol Identification Number
NCT01265173
Brief Title
Comparison of Efficacy of Cefotaxime, Ceftriaxone, and Ciprofloxacin for the Treatment of SBP in Patients With LC
Official Title
Comparison of Efficacy of Cefotaxime, Ceftriaxone, and Ciprofloxacin for the Treatment of Spontaneous Bacterial Peritonitis in Patients With Liver Cirrhosis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
June 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Korea University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SBP, Liver Cirrhosis
Keywords
SBP, liver cirrhosis, antibiotics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
261 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cefotaxime
Arm Type
Active Comparator
Arm Description
iv 2G q 8hrs for general, dose titration if needed (eg.CKD)
Arm Title
Ceftriaxone
Arm Type
Experimental
Arm Description
iv 2G q 24hrs
Arm Title
Ciprofloxacine
Arm Type
Experimental
Arm Description
iv 400mg q 12hrs for general, dose titration if needed (eg.CKD)
Intervention Type
Drug
Intervention Name(s)
Cefotaxime
Intervention Description
3 g
Intervention Type
Drug
Intervention Name(s)
Ceftriaxone
Intervention Description
2 g
Intervention Type
Drug
Intervention Name(s)
Ciprofloxacin
Intervention Description
400 mg
Primary Outcome Measure Information:
Title
Infection resolution rates within 5 days of treatment
Description
PMN < 250/mm3 from ascitic fluid
Time Frame
5 days (120 hours)
Secondary Outcome Measure Information:
Title
Mortality & recurrence rates within 1 month
Description
Mortality
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Liver cirrhosis patients with ascites Ascitic fluid PMN cell count >250/mm3 Age: 16~70 years old Exclusion Criteria: Allergic to 3rd generation cephalosporin or quinolone Antibiotics within 2 weeks Open abdominal surgery within 4 weeks Evidence of 2ndary peritonitis, intrabdominal hemorrhage, pancreatitis, Tb peritonitis, or peritoneal carcinomatosis HCC with portal vein thrombosis Pregnant woman HIV positive
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Soon Ho Um, Professor
Organizational Affiliation
Korea University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Korea University Ansan Hospital
City
Ansan
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
136705
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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