Norfloxacin Versus Ciprofloxacin for Spontaneous Bacterial Peritonitis (SBP) Prevention
- 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.
Adverse Reaction to Other Drugs and Medicines
|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|
- 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.
- 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.
|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)|
Active Comparator: Norfloxacin
norfloxacin 400 mg once daily administration
Norfloxacin 400 mg per day
Ciprofloxacin 750 mg per week
Ciprofloxacin 750 mg per week
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01542801
|Contact: Soon Ho Um, M.D., Ph.D.||email@example.com|
|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 firstname.lastname@example.org|
|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 email@example.com|
|Contact: Yeon Seok Seo, M.D., Ph.D. 82-70-7557-9928 firstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator: Byung Ik Kim, M.D.|
|Principal Investigator:||Soon Ho Um, M.D., Ph.D.||Korea University Anam Hospital|
|Study Director:||Hyung Joon Yim, M.D., Ph.D.||Korea University|