Liver Cirrhosis, SBP
Conditions
Keywords
SBP, liver cirrhosis, antibiotics
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.
Interventions
DRUGCefotaxime
3 g
DRUGCeftriaxone
2 g
DRUGCiprofloxacin
400 mg
Sponsors
Korea University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infection resolution rates within 5 days of treatment | 5 days (120 hours) | PMN \< 250/mm3 from ascitic fluid |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality & recurrence rates within 1 month | 1 month | Mortality |
Countries
South Korea
Outcome results
None listed