6/28/23, 12:26 AM Ceftriaxone prophylaxis in cirrhosis with GI bleeding Pathway Feedback Search Clinical Topics Home Studies Ceftriaxone prophylaxis in cirrhosis with GI bleeding Ceftriaxone prophylaxis in cirrhosis with GI bleeding Disease Disease Liver cirrhosis Variceal hemorrhage Trial question What is the role of ceftriaxone in the prophylaxis of bacterial infections in patients with advanced cirrhosis and hemorrhage? Study design Multi-center Open label RCT Population Characteristics of study participants 23.0% female N = 111 77.0% male 111 patients (25 female, 86 male) Inclusion criteria: patients with advanced cirrhosis (at least 2 of the following: ascites, severe malnutrition, encephalopathy, or bilirubin > 3 mg/dL) and gastrointestinal hemorrhage Key exclusion criteria: allergy to cephalosporins or quinolones, pneumonia, previously diagnosed advanced HCC, and human immunodeficiency virus (HIV) infection Interventions N=54 ceftriaxone (intravenous dosage of 1 g/day for 7 days) N=57 norfloxacin (oral dosage of 400 mg BID for 7 days) Primary outcome Proved or possible infections at 10 days 33.0 % 33 https://web.pathway.md/studies/rectPQdlsWq6rKBrH 1/2 6/28/23, 12:26 AM Ceftriaxone prophylaxis in cirrhosis with GI bleeding Pathway 24.8 % 16.5 % Significant decrease 11 8.3 % NNT = 5 0.0 % Ceftriaxone Norfloxacin Significant decrease in proved or possible infections at 10 days (11% vs. 33%; RR 0.33, 95% CI 0.11 to 0.55) Secondary outcomes Significant decrease in proved infections (11% vs. 26%; RR 0.42, 95% CI 0.04 to 0.8) Significant decrease in spontaneous bacteremia or SBP (2% vs. 12%; RR 0.17, 95% CI 0.02 to 0.32) Safety outcomes No significant difference in hospital mortality. Conclusion In patients with advanced cirrhosis (at least 2 of the following: ascites, severe malnutrition, encephalopathy, or bilirubin > 3 mg/dL) and gastrointestinal hemorrhage, ceftriaxone was superior to norfloxacin with respect to proved or possible infections at 10 days. Reference Fernandez J, Ruiz del Arbol L, Gomez C et al. Norfloxacin vs ceftriaxone in the prophylaxis of infections in patients with advanced cirrhosis and hemorrhage. Gastroenterology. 2006 Oct;131(4):1049-56. Open reference URL https://web.pathway.md/studies/rectPQdlsWq6rKBrH 2/2