Norfloxacin In The Primary Prophylaxis Of Spontaneous Bacterial Peritonitis
Status:
Completed
Trial end date:
2005-03-01
Target enrollment:
Participant gender:
Summary
Advanced liver disease and low ascitic fluid protein concentration have been identified as
risk factors for spontaneous bacterial peritonitis in cirrhosis. Moreover, renal impairment
and hyponatremia increase mortality rate of this infection. Aims: To investigate if oral
administration of norfloxacin prevents the first episode of SBP, hepatorenal syndrome and
improves survival in cirrhotic patients with ascites and low protein concentration in ascitic
fluid (<15 g/L) and at least one of the following inclusion criteria: functional renal
failure (serum creatinine ≥ 1,2 mg/dl or BUN ≥ 25 mg/dl), hyponatremia (serum sodium ≤ 130
mEq/L) or advanced liver disease (Child ≥ 9 points with serum bilirubin ≥ 3 mg/dl). Methods:
Prospective, multicenter, randomized, double-blind placebo controlled trial comparing oral
norfloxacin (400 mg/d; n=35) with placebo (n=35).