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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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SBP, Liver Cirrhosis

Intervention / Treatment
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* Drug: Cefotaxime
* Drug: Ceftriaxone
* Drug: Ciprofloxacin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cefotaxime<br>iv 2G q 8hrs for general, dose titration if needed (eg.CKD) | Drug: Cefotaxime<br>* 3 g<br>|
| Experimental: Ceftriaxone<br>iv 2G q 24hrs | Drug: Ceftriaxone<br>* 2 g<br>|
| Experimental: Ciprofloxacine<br>iv 400mg q 12hrs for general, dose titration if needed (eg.CKD) | Drug: Ciprofloxacin<br>* 400 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infection resolution rates within 5 days of treatment | PMN < 250/mm3 from ascitic fluid | 5 days (120 hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality & recurrence rates within 1 month | Mortality | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SBP, liver cirrhosis, antibiotics