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| Name | Class |
|---|---|
| Sungkyunkwan University | OTHER |
| Kyungpook National University Hospital | OTHER |
| Soon Chun Hyang University | OTHER |
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Spontaneous bacterial peritonitis (SBP) is one of the most serious complication of liver cirrhosis.
The short term mortality reaches 20-30% mainly due to sepsis, hepatorenal syndrome, and liver failure. In addition, patients who suffered SBP show poor prognosis with 1 year-mortality of 50-70%. The high recurrence rate is also problematic. Therefore appropriate prevention of SBP is critically needed to improve survival as well as quality of life.
Selective intestinal decontamination (SID) is eradicating gram negative bacterial in the gut lumen, and effectively prevent development of SBP. Patients with gastrointestinal hemorrhage, low ascitic protein level, high bilirubin, or history of SBP need SID.
Norfloxacin 400 mg daily administration decreased the incidence of SBP to 2% compared with 17% of no prevention group's among patients with ascitic protein less than 1.5 g/dL. Also, in high risk patients (Child-Pugh score > or = 9 points and serum bilirubin level > or = 3 mg/dL, serum creatinine level > or = 1.2 mg/dL, blood urea nitrogen level > or = 25 mg/dL, or serum sodium level < or = 130 mEq/L), norfloxacin 400 mg/day improved 1 year-survival to 60% compared with 48% of no prevention group's. Therefore norfloxacin is now primarily recommend for the prevention of SBP in cirrhotic patients. However, norfloxacin should be administered on daily basis, so efforts to reduce cost and frequency have been made.
Ciprofloxacin 750 mg weekly administration has been evaluated, and shown to be effective as 3.6% versus 22% in prevention versus no prevention arm, respectively. Therefore, ciprofloxacin 750 mg/week is a reasonable option for prevention of SBP. However, comparison of efficacy of these two methods (norfloxacin 400 mg daily versus ciprofloxacin 750 mg weekly) has not been performed, yet.
The investigators aim to compare the efficacy and safety of norfloxacin 400 mg daily and ciprofloxacin 750 mg weekly for the proper management of cirrhotic patients with ascites.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Norfloxacin | Active Comparator | norfloxacin 400 mg once daily administration |
|
| Ciprofloxacin | Experimental | Ciprofloxacin 750 mg per week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Norfloxacin | Drug | Norfloxacin 400 mg per day |
| |
| ciprofloxacin |
| Measure | Description | Time Frame |
|---|---|---|
| The prevention rate of spontaneous bacterial peritonitis (SBP) | The incidence of SBP will measured in each the group. Thereby, prevention rate will also be compared between the groups. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 1 year mortality | liver related mortality and overall mortality will be assessed. | 12 months ( 1 year) |
| Incidence of infectious event other than SBP | Bacteremia, urinary tract infection, pneumonia, and other infections will be included. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Soon Ho Um, M.D., Ph.D. | Korea University Anam Hospital | Principal Investigator |
| Hyung Joon Yim, M.D., Ph.D. | Korea University Ansan Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Ansan Hospital | Ansan | Gyeonggi-do | South Korea | |||
| Soonchunhyang University College of Medicine, Bucheon Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11736714 | Background | Mowat C, Stanley AJ. Review article: spontaneous bacterial peritonitis--diagnosis, treatment and prevention. Aliment Pharmacol Ther. 2001 Dec;15(12):1851-9. doi: 10.1046/j.1365-2036.2001.01116.x. | |
| 17551068 | Background | Koulaouzidis A, Bhat S, Karagiannidis A, Tan WC, Linaker BD. Spontaneous bacterial peritonitis. Postgrad Med J. 2007 Jun;83(980):379-83. doi: 10.1136/pgmj.2006.056168. |
| Label | URL |
|---|---|
| Korea University (PI of SBP\_prevention study is belong to this university) | View source |
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| ID | Term |
|---|---|
| D009643 | Norfloxacin |
| D002939 | Ciprofloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| Drug |
Ciprofloxacin 750 mg per week |
|
| 12 months |
| Hepatorenal syndrome | Diagnostic criteria of hepatorenal syndrome is defined by the latest version of Internation ascites club consensus. | 12 months |
| Hepatic encephalopathy | Will follow the Western Heaven Criteria. | 12 months |
| Adverse event of drugs | Any of adverse event suspected by study drugs will be recorded. | 12 months |
| Bucheon-si |
| South Korea |
| Soonchunhyang University College of Medicine, Cheonan Hospital | Cheonan | South Korea |
| Kyungpuk National University Hospital | Daegu | South Korea |
| Korea University Anam Hospital | Seoul | South Korea |
| Soonchunhyang University College of Medicine, Seoul Hospital | Seoul | South Korea |
| Sungkyunkwan University Gangbuk Samsung Hospital | Seoul | South Korea |
| 11786970 | Background | Fernandez J, Navasa M, Gomez J, Colmenero J, Vila J, Arroyo V, Rodes J. Bacterial infections in cirrhosis: epidemiological changes with invasive procedures and norfloxacin prophylaxis. Hepatology. 2002 Jan;35(1):140-8. doi: 10.1053/jhep.2002.30082. |
| 20633946 | Background | European Association for the Study of the Liver. EASL clinical practice guidelines on the management of ascites, spontaneous bacterial peritonitis, and hepatorenal syndrome in cirrhosis. J Hepatol. 2010 Sep;53(3):397-417. doi: 10.1016/j.jhep.2010.05.004. Epub 2010 Jun 1. No abstract available. |
| 7557868 | Result | Rolachon A, Cordier L, Bacq Y, Nousbaum JB, Franza A, Paris JC, Fratte S, Bohn B, Kitmacher P, Stahl JP, et al. Ciprofloxacin and long-term prevention of spontaneous bacterial peritonitis: results of a prospective controlled trial. Hepatology. 1995 Oct;22(4 Pt 1):1171-4. doi: 10.1016/0270-9139(95)90626-6. |
| 9764990 | Result | Grange JD, Roulot D, Pelletier G, Pariente EA, Denis J, Ink O, Blanc P, Richardet JP, Vinel JP, Delisle F, Fischer D, Flahault A, Amiot X. Norfloxacin primary prophylaxis of bacterial infections in cirrhotic patients with ascites: a double-blind randomized trial. J Hepatol. 1998 Sep;29(3):430-6. doi: 10.1016/s0168-8278(98)80061-5. |
| 17854593 | Result | Fernandez J, Navasa M, Planas R, Montoliu S, Monfort D, Soriano G, Vila C, Pardo A, Quintero E, Vargas V, Such J, Gines P, Arroyo V. Primary prophylaxis of spontaneous bacterial peritonitis delays hepatorenal syndrome and improves survival in cirrhosis. Gastroenterology. 2007 Sep;133(3):818-24. doi: 10.1053/j.gastro.2007.06.065. Epub 2007 Jul 3. |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |