6/28/23, 11:22 PM Norfloxacin for primary SBP prophylaxis Pathway Feedback Search Clinical Topics Home Studies Norfloxacin for primary SBP prophylaxis Norfloxacin for primary SBP prophylaxis Disease Spontaneous bacterial peritonitis Trial question What is the role of norfloxacin in patients with cirrhosis and low ascitic fluid protein levels (< 15 g/L)? Study design Multi-center Double blinded RCT Population Characteristics of study participants 36.0% female N = 107 64.0% male 107 patients (38 female, 68 male) Inclusion criteria: patients with cirrhosis and low ascitic fluid protein levels (< 15 g/L) who had no history of infection and no active infection since cirrhosis diagnosis Key exclusion criteria: active gastrointestinal bleeding on admission, HCC or other life-threatening disease or failure to provide written informed consent Interventions N=53 norfloxacin (400 mg/day for 6 months) N=54 placebo (matching placebo daily for 6 months) Primary outcome https://web.pathway.md/studies/recbMMXeQNhkVwukY 1/2 6/28/23, 11:22 PM Norfloxacin for primary SBP prophylaxis Pathway Significant decrease in gram-negative infection (ARD -11, 95% CI -20.12 to -1.88) Safety outcomes No significant difference in mortality. Conclusion In patients with cirrhosis and low ascitic fluid protein levels (< 15 g/L) who had no history of infection and no active infection since cirrhosis diagnosis, norfloxacin was superior to placebo with respect to a gram-negative infection. Reference Grange JD, Roulot D, Pelletier G et al. Norfloxacin primary prophylaxis of bacterial infections in cirrhotic patients with ascites: a double-blind randomized trial. J Hepatol. 1998 Sep;29(3):430-6. Open reference URL https://web.pathway.md/studies/recbMMXeQNhkVwukY 2/2