Daily Norfloxacin vs. Weekly Ciprofloxacin to Prevent Spontaneous Bacterial Peritonitis: A Randomized Controlled Trial

• Published in: The American journal of gastroenterology Vol. 113; no. 8; pp. 1167 - 1176
• Main Authors: Yim, Hyung Joon, Suh, Sang Jun, Jung, Young Kul, Yim, Sun Young, Seo, Yeon Seok, Lee, Yu Rim, Park, Soo Young, Jang, Jae Young, Kim, Young Seok, Kim, Hong Soo, Kim, Byung Ik, Um, Soon Ho
• Format: Journal Article
• Language: English
• Published: United States Wolters Kluwer Health Medical Research, Lippincott Williams & Wilkins 01.08.2018
• Subjects: Adult; Aged; Anti-Bacterial Agents - administration & dosage; Anti-Bacterial Agents - therapeutic use; Antibiotics; Ascites; Bacterial Infections - drug therapy; Bacterial Infections - prevention & control; Ciprofloxacin - administration & dosage; Ciprofloxacin - therapeutic use; Clinical trials; Disease-Free Survival; Drug Administration Schedule; Female; Gastroenterology; Gastrointestinal Hemorrhage - drug therapy; Gastrointestinal Hemorrhage - prevention & control; Humans; Liver Cirrhosis; Male; Middle Aged; Norfloxacin - administration & dosage; Norfloxacin - therapeutic use; Peritonitis - drug therapy; Peritonitis - prevention & control; Prevention; Republic of Korea; Treatment Outcome; Young Adult; Republic of Korea
• ISSN: 0002-9270; 1572-0241
• DOI: 10.1038/s41395-018-0168-7

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. 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 . Patients were randomly assigned into norfloxacin daily or ciprofloxacin weekly group, and followed-up for 12 months. Primary endpoint was the prevention of SBP. 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. Once weekly ciprofloxacin was as effective as daily norfloxacin for the prevention of SBP in cirrhotic patients with ascites.