Results of a randomized control trial of patients with advanced cirrhosis without recent fluoroquinolone therapy showed that norfloxacin did not reduce 6-month mortality but did appear to increase survival among patients with low ascites fluid protein concentration.
“Of note, the beneficial effect of norfloxacin on the risk of any infection and Gram-negative bacterial infections, was maintained, and even extended to Gram-positive bacterial infections, during the double-blind post-treatment period,” Richard Moreau, MD, from the Assistance Publique – Hôpitaux de Paris, and colleagues wrote. “Since 77% of the enrolled patients had alcoholic cirrhosis, our results mainly apply to patients with alcoholic cirrhosis.”
Moreau and colleagues randomly assigned 144 patients to receive norfloxacin and 147 to receive placebo.
At 6 months, the mortality rate was similar between the norfloxacin group (n = 19; 95% CI, 9.3-21.6) and the control group (n = 27; 95% CI, 13.5-26.8), which confirmed a nonsignificant reduction in mortality between the two groups (HR = 0.69; 95% CI, 0.38-1.23).
Baseline ascitic fluid protein levels were available in 66.8% of patients with ascites from the combined cohorts. Among the 102 patients with levels less than 15 g per liter, 6-month cumulative mortality was significantly lower in the norfloxacin group than controls (HR = 0.35; 95% CI, 0.13-0.93).
In contrast, 6-month cumulative mortality among the 53 patients with ascitic fluid protein levels of 15 g per liter or higher did not differ between the treatment and placebo groups.
The researchers report no serious adverse events correlated with study treatment.
Regarding secondary outcomes, the cumulative incidence of any infection was significantly lower in the norfloxacin group than controls, including the Gram-negative bacterial infections. Rates of spontaneous bacterial peritonitis and infections caused by multidrug resistant bacteria were similar between the groups.
“Although these results should be interpreted with caution, in particular because of missing data regarding ascitic fluid protein levels in some patients, they strongly suggest, along with previous findings obtained in an independent study, that patients with advanced cirrhosis and low ascitic fluid protein levels are good candidates for prolonged norfloxacin administration to decrease mortality,” the researchers concluded. – by Talitha Bennett
Disclosure: Moreau reports no relevant financial disclosures. Please see the full study for the other authors’ relevant financial disclosures.