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

Liver Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01265173
• Other study ID #: CCCCSBP
• Status: Completed
• Phase: Phase 4
• Start date: April 2007
• Est. completion date: June 2018

Study information

• Verified date: April 2020
• Source: Korea University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 261
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• Liver Cirrhosis
• SBP

Intervention

Drug:
• Cefotaxime
3 g
• Ceftriaxone
2 g
• Ciprofloxacin
400 mg

Locations

Country	Name	City	State
Korea, Republic of	Korea University Ansan Hospital	Ansan
Korea, Republic of	Korea University Anam Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Korea University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infection resolution rates within 5 days of treatment	PMN < 250/mm3 from ascitic fluid	5 days (120 hours)
Secondary	Mortality & recurrence rates within 1 month	Mortality	1 month