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

Sponsor

Korea University (Other)

Overall Status

Completed

CT.gov ID

NCT01265173

Collaborator

(none)

261

Enrollment

Locations

Arms

134

Duration (Months)

130.5

Patients Per Site

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
SBP Liver Cirrhosis	Drug: Cefotaxime Drug: Ceftriaxone Drug: Ciprofloxacin	Phase 4

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

261 participants

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

Study Start Date :

Apr 1, 2007

Actual Primary Completion Date :

Jun 1, 2018

Actual Study Completion Date :

Jun 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Infection resolution rates within 5 days of treatment [5 days (120 hours)]
PMN < 250/mm3 from ascitic fluid

Secondary Outcome Measures

Mortality & recurrence rates within 1 month [1 month]
Mortality

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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