Objectives: For the prevention of spontaneous bacterial peritonitis (SBP) in cirrhotic patients with ascites, norfloxacin 400 mg per day is recommended as a standard regimen. This study aims to investigate whether ciprofloxacin once weekly administration is not inferior to norfloxacin once daily administration for the prevention of SBP. Methods: This is an investigator-initiated open-label randomized controlled trial conducted at seven tertiary hospitals in South Korea. Liver cirrhosis patients with ascites were screened, and enrolled in this randomized controlled trial if ascitic protein ≤1.5 g/dL or the presence of history of SBP. Ascitic polymorphonucleated cell count needed to be <250/mm 3 . Patients were randomly assigned into norfloxacin daily or ciprofloxacin weekly group, and followed-up for 12 months. Primary endpoint was the prevention of SBP. Results: One hundred twenty-four patients met enrollment criteria and were assigned into each group by 1:1 ratio (62:62). Seven patients in the norfloxacin group and five patients in the ciprofloxacin group were lost to follow-up. SBP developed in four patients (4/55) and in three patients (3/57) in each group, respectively (7.3% vs. 5.3%, P = 0.712). The transplant-free survival rates at 1 year were comparable between the groups (72.7% vs. 73.7%, P = 0.970). Incidence of infectious complication, hepatorenal syndrome, hepatic encephalopathy, and variceal bleeding rates were not significantly different (all P = ns). The factors related to survival were models representing underlying liver function. Conclusion: Once weekly ciprofloxacin was as effective as daily norfloxacin for the prevention of SBP in cirrhotic patients with ascites.
Bibliographical noteFunding Information:
Guarantor of the article: Soon Ho Um, M.D., Ph.D. Specific author contributions: Study conception and design: YHJ and USH; Obtaining fund: USH; Acquisition of data: YHJ, SSJ, JYG, YSY, SYS, LYR, PSY, JJY, KYS, KHS, KBI, and USH; Data analysis and interpretation: YHJ and SSJ; Writing of report: YHJ; Review and final approval of the submission of the manuscript: YHJ, SSJ, JYG, YSY, SYS, LYR, PSY, JJY, KYS, KHS, KBI, and USH. Financial support: This study was partly funded by a grant of the Korea Healthcare Technology R&D Project, Ministry of Health and Welfare, Republic of Korea (HI10C2020), and partly by Korea University Research Grant. Potential competing interests: None.
© 2018, American College of Gastroenterology.
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