Ceftriaxone prophylaxis in cirrhosis with GI bleeding
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
77.0% male
N = 111
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 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
11%
33%
33.0 %
24.8 %
16.5 %
8.3 %
0.0 %
Ceftriaxone
Norfloxacin
Significant
decrease ▼
NNT = 4
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.
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