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Norfloxacin Versus Ciprofloxacin for Spontaneous Bacterial Peritonitis (SBP) Prevention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01542801
Recruitment Status : Completed
First Posted : March 2, 2012
Last Update Posted : December 28, 2016
Sungkyunkwan University
Kyungpook National University
Soon Chun Hyang University
Information provided by (Responsible Party):
Soon Ho Um, Korea University

Brief 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.

Condition or disease Intervention/treatment Phase
Adverse Reaction to Other Drugs and Medicines Drug: Norfloxacin Drug: ciprofloxacin Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Comparison of Daily Norfloxacin Versus Weekly Ciprofloxacin for the Prevention of Spontaneous Bacterial Peritonitis in Cirrhotic Patients
Study Start Date : August 2011
Actual Primary Completion Date : July 2015
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Norfloxacin
norfloxacin 400 mg once daily administration
Drug: Norfloxacin
Norfloxacin 400 mg per day

Experimental: Ciprofloxacin
Ciprofloxacin 750 mg per week
Drug: ciprofloxacin
Ciprofloxacin 750 mg per week

Primary Outcome Measures :
  1. The prevention rate of spontaneous bacterial peritonitis (SBP) [ Time Frame: 12 months ]
    The incidence of SBP will measured in each the group. Thereby, prevention rate will also be compared between the groups.

Secondary Outcome Measures :
  1. 1 year mortality [ Time Frame: 12 months ( 1 year) ]
    liver related mortality and overall mortality will be assessed.

  2. Incidence of infectious event other than SBP [ Time Frame: 12 months ]
    Bacteremia, urinary tract infection, pneumonia, and other infections will be included.

  3. Hepatorenal syndrome [ Time Frame: 12 months ]
    Diagnostic criteria of hepatorenal syndrome is defined by the latest version of Internation ascites club consensus.

  4. Hepatic encephalopathy [ Time Frame: 12 months ]
    Will follow the Western Heaven Criteria.

  5. Adverse event of drugs [ Time Frame: 12 months ]
    Any of adverse event suspected by study drugs will be recorded.

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01542801

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Korea, Republic of
Korea University Ansan Hospital
Ansan, Gyeonggi-do, Korea, Republic of
Soonchunhyang University College of Medicine, Bucheon Hospital
Bucheon, Korea, Republic of
Soonchunhyang University College of Medicine, Cheonan Hospital
Cheonan, Korea, Republic of
Kyungpuk National University Hospital
Daegu, Korea, Republic of
Korea University Anam Hospital
Seoul, Korea, Republic of
Soonchunhyang University College of Medicine, Seoul Hospital
Seoul, Korea, Republic of
Sungkyunkwan University Gangbuk Samsung Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Korea University
Sungkyunkwan University
Kyungpook National University
Soon Chun Hyang University
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Principal Investigator: Soon Ho Um, M.D., Ph.D. Korea University Anam Hospital
Study Director: Hyung Joon Yim, M.D., Ph.D. Korea University

Additional Information:
Publications of Results:
Other Publications:
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Responsible Party: Soon Ho Um, Professor of Medicine, Korea University Identifier: NCT01542801     History of Changes
Other Study ID Numbers: SBP_prevention
First Posted: March 2, 2012    Key Record Dates
Last Update Posted: December 28, 2016
Last Verified: December 2016

Keywords provided by Soon Ho Um, Korea University:
Effect of Preventive Antibiotics

Additional relevant MeSH terms:
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Intraabdominal Infections
Peritoneal Diseases
Digestive System Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors