Norfloxacin Versus Ciprofloxacin for Spontaneous Bacterial Peritonitis (SBP) Prevention

• Status: Completed
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Korea University
• Collaborators: Hanyang University; Kyungpook National University; Kyungpook National University Hospital; Pusan National University; Soon Chun Hyang University; Sungkyunkwan University; Yonsei University
• Treatments: Ciprofloxacin; Norfloxacin

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