Norfloxacin Versus Ciprofloxacin for Spontaneous Bacterial Peritonitis (SBP) Prevention

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Korea University
Sponsor:
Collaborators:
Sungkyunkwan University
Kyungpook National University
Pusan National University School of Medicine
Yonsei University
Soon Chun Hyang University
Hanyang University
Information provided by (Responsible Party):
Soon Ho Um, Korea University
ClinicalTrials.gov Identifier:
NCT01542801
First received: February 26, 2012
Last updated: April 8, 2014
Last verified: April 2014
  Purpose
  • 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 Intervention Phase
Adverse Reaction to Other Drugs and Medicines
Drug: Norfloxacin
Drug: ciprofloxacin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Comparison of Daily Norfloxacin Versus Weekly Ciprofloxacin for the Prevention of Spontaneous Bacterial Peritonitis in Cirrhotic Patients

Resource links provided by NLM:


Further study details as provided by Korea University:

Primary Outcome Measures:
  • The prevention rate of spontaneous bacterial peritonitis (SBP) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The incidence of SBP will measured in each the group. Thereby, prevention rate will also be compared between the groups.


Secondary Outcome Measures:
  • 1 year mortality [ Time Frame: 12 months ( 1 year) ] [ Designated as safety issue: Yes ]
    liver related mortality and overall mortality will be assessed.

  • Incidence of infectious event other than SBP [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Bacteremia, urinary tract infection, pneumonia, and other infections will be included.

  • Hepatorenal syndrome [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Diagnostic criteria of hepatorenal syndrome is defined by the latest version of Internation ascites club consensus.

  • Hepatic encephalopathy [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Will follow the Western Heaven Criteria.

  • Adverse event of drugs [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Any of adverse event suspected by study drugs will be recorded.


Estimated Enrollment: 122
Study Start Date: August 2011
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01542801

Contacts
Contact: Soon Ho Um, M.D., Ph.D. 82-10-3311-8102 umsh@korea.ac.kr

Locations
Korea, Republic of
Korea University Ansan Hospital Recruiting
Ansan, Gyeonggi-do, Korea, Republic of
Contact: Hyung Joon Yim, M.D., Ph.D.         
Principal Investigator: Hyung Joon Yim, M.D., Ph.D.         
Kyungpuk National University Hospital Recruiting
Daegu, Korea, Republic of
Contact: Soo Young Park, M.D.    82-17-515-3619    psyoung@medimail.co.kr   
Principal Investigator: Soo Young Park, M.D.         
Sub-Investigator: Won Young Tak, M.D.         
Korea University Anam Hospital Recruiting
Seoul, Korea, Republic of
Contact: Soon Ho Um    82-10-3311-8102    umsh@korea.ac.kr   
Contact: Yeon Seok Seo, M.D., Ph.D.    82-70-7557-9928    drseo@korea.ac.kr   
Principal Investigator: Soon Ho Um, M.D., Ph.D.         
Sungkyunkwan University Gangbuk Samsung Hospital Recruiting
Seoul, Korea, Republic of
Contact: Byung Ik Kim, M.D.    82-11-757-7424    bik.kim@samsung.com   
Principal Investigator: Byung Ik Kim, M.D.         
Sponsors and Collaborators
Korea University
Sungkyunkwan University
Kyungpook National University
Pusan National University School of Medicine
Yonsei University
Soon Chun Hyang University
Hanyang University
Investigators
Principal Investigator: Soon Ho Um, M.D., Ph.D. Korea University Anam Hospital
Study Director: Hyung Joon Yim, M.D., Ph.D. Korea University
  More Information

Additional Information:
Publications:

Responsible Party: Soon Ho Um, Professor of Medicine, Korea University
ClinicalTrials.gov Identifier: NCT01542801     History of Changes
Other Study ID Numbers: SBP_prevention
Study First Received: February 26, 2012
Last Updated: April 8, 2014
Health Authority: Korea: Food and Drug Administration

Keywords provided by Korea University:
Effect of Preventive Antibiotics

Additional relevant MeSH terms:
Peritoneal Diseases
Peritonitis
Intraabdominal Infections
Infection
Digestive System Diseases
Ciprofloxacin
Norfloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 28, 2014