Allen Barbarovich, Rahul Patel, Hardeep Singh, Jake Slaton, Nelson A Royall
No statistically significant differences in CDI incidence or all-cause mortality were observed between prophylactic regimens. However, low event rates resulted in wide confidence intervals, limiting precision and precluding conclusions regarding comparative effectiveness or equivalence. Larger studies are warranted to validate these observations.
BACKGROUND: Spontaneous bacterial peritonitis (SBP) remains a life-threatening complication in patients with cirrhosis and ascites. Preventing recurrence is a major clinical objective, and prophylactic antibiotic strategies are routinely implemented. Ciprofloxacin and trimethoprim-sulfamethoxazole (TMP-SMX) are two widely used alternatives to norfloxacin, especially in regions where norfloxacin is not available. However, comparative data on adverse outcomes such as Clostridioides difficile infection (CDI) and mortality remain scarce. This retrospective cohort study examined the incidence of CDI and mortality in cirrhotic patients receiving ciprofloxacin or TMP-SMX for secondary SBP prophylaxis.
METHODS: A total of 6,948 patient encounters were analyzed. Ciprofloxacin was used in 75.4% (5,236) and TMP-SMX in 24.6% (1,712) of cases.
RESULTS: CDI occurred in 0.4% (21) of ciprofloxacin recipients and 0.6% (11) of TMP-SMX recipients. Mortality rates were 0.3% and 0.6%, respectively. A generalized estimating equation (GEE) model showed no statistically significant difference in CDI risk (odds ratio (OR) = 0.623; 95% confidence interval (CI): 0.299-1.296; P = 0.206) or mortality (OR = 0.539; 95% CI: 0.158-1.844; P = 0.320). These findings suggest no statistically significant difference in adverse outcomes between the two regimens, although low event rates may have limited the statistical power of the analysis.
CONCLUSION: No statistically significant differences in CDI incidence or all-cause mortality were observed between prophylactic regimens. However, low event rates resulted in wide confidence intervals, limiting precision and precluding conclusions regarding comparative effectiveness or equivalence. Larger studies are warranted to validate these observations.