Norfloxacin Versus Ciprofloxacin for Spontaneous Bacterial Peritonitis (SBP) Prevention
Information source: Korea University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Adverse Reaction to Other Drugs and Medicines
Intervention: Norfloxacin (Drug); ciprofloxacin (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Korea University Official(s) and/or principal investigator(s): Soon Ho Um, M.D., Ph.D., Principal Investigator, Affiliation: Korea University Anam Hospital Hyung Joon Yim, M.D., Ph.D., Study Director, Affiliation: Korea University
Overall contact: Soon Ho Um, M.D., Ph.D., Phone: 82-10-3311-8102, Email: umsh@korea.ac.kr
Summary
- For the prevention of spontaneous bacterial peritonitis (SBP) in patients with liver
cirrhosis, norfloxacin 400mg per day is a standard regimen.
- 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.
Clinical Details
Official title: Comparison of Daily Norfloxacin Versus Weekly Ciprofloxacin for the Prevention of Spontaneous Bacterial Peritonitis in Cirrhotic Patients
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: The prevention rate of spontaneous bacterial peritonitis (SBP)
Secondary outcome: 1 year mortalityIncidence of infectious event other than SBP Hepatorenal syndrome Hepatic encephalopathy Adverse event of drugs
Detailed description:
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.
Eligibility
Minimum age: 20 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Age between 20-75 years old
- Liver cirrhosis with ascites
- Ascitic polymorphonucleated cells (PMN) count < 250/mm3
- Ascitic protein <= 1. 5 g/dL or History of SBP
Exclusion Criteria:
- Incompatibility with inclusion criteria
- 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
Locations and Contacts
Soon Ho Um, M.D., Ph.D., Phone: 82-10-3311-8102, Email: umsh@korea.ac.kr
Kyungpuk National University Hospital, Daegu, Korea, Republic of; Recruiting Soo Young Park, M.D., Phone: 82-17-515-3619, Email: psyoung@medimail.co.kr Soo Young Park, M.D., Principal Investigator Won Young Tak, M.D., Sub-Investigator
Korea University Anam Hospital, Seoul, Korea, Republic of; Recruiting Soon Ho Um, Phone: 82-10-3311-8102, Email: umsh@korea.ac.kr Yeon Seok Seo, M.D., Ph.D., Phone: 82-70-7557-9928, Email: drseo@korea.ac.kr Soon Ho Um, M.D., Ph.D., Principal Investigator
Sungkyunkwan University Gangbuk Samsung Hospital, Seoul, Korea, Republic of; Recruiting Byung Ik Kim, M.D., Phone: 82-11-757-7424, Email: bik.kim@samsung.com Byung Ik Kim, M.D., Principal Investigator
Korea University Ansan Hospital, Ansan, Gyeonggi-do, Korea, Republic of; Recruiting Hyung Joon Yim, M.D., Ph.D. Hyung Joon Yim, M.D., Ph.D., Principal Investigator
Additional Information
Liver cirrhosis clinical research center (PI of SBP_prevention study is belong to this center) Korea University (PI of SBP_prevention study is belong to this university)
Related publications: Mowat C, Stanley AJ. Review article: spontaneous bacterial peritonitis--diagnosis, treatment and prevention. Aliment Pharmacol Ther. 2001 Dec;15(12):1851-9. Review. Koulaouzidis A, Bhat S, Karagiannidis A, Tan WC, Linaker BD. Spontaneous bacterial peritonitis. Postgrad Med J. 2007 Jun;83(980):379-83. Review. Fernández J, Navasa M, Gómez J, Colmenero J, Vila J, Arroyo V, Rodés J. Bacterial infections in cirrhosis: epidemiological changes with invasive procedures and norfloxacin prophylaxis. Hepatology. 2002 Jan;35(1):140-8. 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. Review.
Starting date: August 2011
Last updated: April 8, 2014
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