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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cefotaxime | Active Comparator | iv 2G q 8hrs for general, dose titration if needed (eg.CKD) |
|
| Ceftriaxone | Experimental | iv 2G q 24hrs |
|
| Ciprofloxacine | Experimental | iv 400mg q 12hrs for general, dose titration if needed (eg.CKD) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cefotaxime | Drug | 3 g |
| |
| Ceftriaxone |
| Measure | Description | Time Frame |
|---|---|---|
| Infection resolution rates within 5 days of treatment | PMN < 250/mm3 from ascitic fluid | 5 days (120 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality & recurrence rates within 1 month | Mortality | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Soon Ho Um, Professor | Korea University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Ansan Hospital | Ansan | South Korea | ||||
| Korea University Anam Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36594820 | Derived | Yim HJ, Kim TH, Suh SJ, Yim SY, Jung YK, Seo YS, Kang SH, Kim MY, Baik SK, Kim HS, Kim YS, Park SY, Kim BI, Park JY, Heo J, Sohn JH, Heo NY, Han KH, Um SH. Response-Guided Therapy With Cefotaxime, Ceftriaxone, or Ciprofloxacin for Spontaneous Bacterial Peritonitis: A Randomized Trial: A Validation Study of 2021 AASLD Practice Guidance for SBP. Am J Gastroenterol. 2023 Apr 1;118(4):654-663. doi: 10.14309/ajg.0000000000002126. Epub 2023 Jan 3. |
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| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D002439 | Cefotaxime |
| D002443 | Ceftriaxone |
| D002939 | Ciprofloxacin |
| ID | Term |
|---|---|
| D002505 | Cephacetrile |
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 |
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| Drug |
2 g |
|
| Ciprofloxacin | Drug | 400 mg |
|
| Seoul |
| 136705 |
| South Korea |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| Amides |
| D009930 | Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |