Ciprofloxacin in primary prophylaxis of spontaneous bacterial peritonitis: a randomized, placebo-controlled study
Rubén Terg1, Eduardo Fassio, Mónica Guevara
1Unidad de Hígado, Hospital de Gastroenterología Dr. Bonorino Udaondo, Sección Hepatología, Avenida Caseros 2061, 1264 Buenos Aires, Argentina. fundhig@speedy.com.ar
Insights
Long-term ciprofloxacin prophylaxis in cirrhotic patients with low ascitic fluid protein significantly improved survival and reduced bacterial infections, suggesting its potential benefit in preventing spontaneous bacterial peritonitis (SBP).
Area of Science:
- Hepatology
- Infectious Diseases
- Clinical Pharmacology
Background:
- Low ascitic fluid protein concentration is a known risk factor for spontaneous bacterial peritonitis (SBP).
- Primary prophylaxis for SBP has not been routinely recommended for these patients.
- This study investigated the efficacy of long-term ciprofloxacin for SBP prevention.
Purpose of the Study:
- To evaluate the efficacy of long-term ciprofloxacin administration in preventing SBP.
- To assess the impact of ciprofloxacin on patient survival rates.
- To determine the effect on the incidence of bacterial infections.
Main Methods:
- A prospective, double-blind, randomized trial involving 100 cirrhotic patients with ascitic fluid protein <1.5 g/dl.
- Patients were randomized to receive either 500 mg/day ciprofloxacin (n=50) or placebo (n=50) for 12 months.
- Outcomes included SBP incidence, survival probability, and bacterial infection rates.
Main Results:
- SBP occurred less frequently in the ciprofloxacin group, though not statistically significant.
- 12-month survival probability was significantly higher in the ciprofloxacin group (86% vs. 66%, p<0.04).
- Patients on ciprofloxacin had a higher probability of remaining infection-free (80% vs. 55%, p=0.05).
- Infections and sepsis were leading causes of death in the placebo group, while gastrointestinal bleeding predominated in the ciprofloxacin group.
Conclusions:
- Long-term ciprofloxacin prophylaxis is a viable strategy for patients with cirrhosis and low ascitic fluid protein.
- This approach can reduce the risk of infections, including SBP.
- Prophylactic ciprofloxacin may improve overall survival in this high-risk patient population.
Background/Aims:
Low protein concentration in ascitic fluid has been identified as a risk factor for spontaneous bacterial peritonitis (SBP). Until now, primary prophylaxis has not been recommended in these patients. The aim was to investigate the efficacy of long-term administration of ciprofloxacin to prevent SBP.
Methods:
One hundred cirrhotic patients with <1.5 g/dl of total protein in ascitic fluid were randomized prospectively, in a double blind fashion to receive ciprofloxacin 500 mg/day (n=50) or placebo (n=50) for 12 months.
Results:
Baseline data were similar in both groups. In the ciprofloxacin group, SBP occurred almost four times less frequently than in the placebo group but it was not statistically significant. The probability of survival at 12 months was significantly higher in patients receiving ciprofloxacin (86% versus 66%) (p<0.04). SBP and sepsis were the most frequent causes of death in the placebo group whereas gastrointestinal bleeding was responsible for the most deaths in the ciprofloxacin group. The probability of remaining free of bacterial infections was higher in patients receiving ciprofloxacin (80% versus 55%) (p=0.05).
Conclusions:
Patients with cirrhosis and low protein concentration in ascitic fluid are candidates to receive long-term prophylaxis to reduce the risk of infections and improve survival.
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