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

Korea University

Status and phase: Completed; Phase 4

Conditions: Liver Cirrhosis; SBP

Treatments: Drug: Ceftriaxone; Drug: Cefotaxime; Drug: Ciprofloxacin

Study type: Interventional

Funder types: Other

Identifiers

NCT01265173

CCCCSBP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 261 patients

Sex: All

Ages: 16 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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261 participants in 3 patient groups

Cefotaxime

Active Comparator group

Description:

iv 2G q 8hrs for general, dose titration if needed (eg.CKD)

Treatment:

Drug: Cefotaxime

Ceftriaxone

Experimental group

Description:

iv 2G q 24hrs

Treatment:

Drug: Ceftriaxone

Ciprofloxacine

Experimental group

Description:

iv 400mg q 12hrs for general, dose titration if needed (eg.CKD)

Treatment:

Drug: Ciprofloxacin