Norfloxacin for primary SBP prophylaxis
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
64.0% male
N = 107
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
Gram-negative infection
0%
11%
-2.8 %
-5.5 %
-8.3 %
-11.0 %
Norfloxacin
Placebo
Significant
decrease ▼
NNT = 9
Significant decrease in gram-negative infection (0% vs. 11%; ARD -11, 95% CI -20.12 to -1.88).
Secondary outcomes
Significant increase in severe infection (2% vs. 17%).
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.
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