Norfloxacin Versus Ciprofloxacin for Spontaneous Bacterial Peritonitis (SBP) Prevention
NCT ID: NCT01542801
Last Updated: 2016-12-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
124 participants
INTERVENTIONAL
2011-08-31
2016-04-30
Brief Summary
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* Ciprofloxacin 750 mg per week is also known to be effective for prevention of SBP. In addition, ciprofloxacin once weekly administration is more convenient and less costly.
* Therefore ciprofloxacin once weekly could be more useful if the the efficacy is comparable to norfloxacin once daily.
* This study aims to prove ciprofloxacin once weekly administration is as effective as norfloxacin once daily administration for the prevention of SBP in cirrhotic patients with ascites.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Norfloxacin
norfloxacin 400 mg once daily administration
Norfloxacin
Norfloxacin 400 mg per day
Ciprofloxacin
Ciprofloxacin 750 mg per week
ciprofloxacin
Ciprofloxacin 750 mg per week
Interventions
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Norfloxacin
Norfloxacin 400 mg per day
ciprofloxacin
Ciprofloxacin 750 mg per week
Eligibility Criteria
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Inclusion Criteria
* Liver cirrhosis with ascites
* Ascitic polymorphonucleated cells (PMN) count \< 250/mm3
* Ascitic protein \<= 1.5 g/dL or History of SBP
* Hypersensitivity or intolerability with quinolones
* Hepatocellular carcinoma beyond Milan Criteria
* Hepatic encephalopathy over stage 2
* History of treatment with antibiotics within 2 weeks of enrollment
* HIV infection
* Untreated malignancy
* Women with child-bearing age not willing to use effective contraception.
* Pregnant or breast feeding women
* Not able to give informed consents
20 Years
75 Years
ALL
No
Sponsors
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Sungkyunkwan University
OTHER
Kyungpook National University Hospital
OTHER
Soon Chun Hyang University
OTHER
Korea University
OTHER
Responsible Party
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Soon Ho Um
Professor of Medicine
Principal Investigators
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Soon Ho Um, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Korea University Anam Hospital
Hyung Joon Yim, M.D., Ph.D.
Role: STUDY_DIRECTOR
Korea University Ansan Hospital
Locations
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Korea University Ansan Hospital
Ansan, Gyeonggi-do, South Korea
Soonchunhyang University College of Medicine, Bucheon Hospital
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
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Related Links
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Korea University (PI of SBP\_prevention study is belong to this university)
Other Identifiers
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SBP_prevention
Identifier Type: -
Identifier Source: org_study_id