Norfloxacin In The Primary Prophylaxis Of Spontaneous Bacterial Peritonitis

Condition(s) targeted: Spontaneous Bacterial Peritonitis; Hepatorenal Syndrome; Cirrhosis

Intervention: Oral norfloxacin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Hospital Clinic of Barcelona

Official(s) and/or principal investigator(s):
Miquel Navasa, MD, Principal Investigator, Affiliation: Liver Unit. Hospital Clinic Barcelona

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).

Official title: Randomized Double-Blid Placebo Controlled Trial Assessing Norfloxacin In The Primary Prophylaxis Of Spontaneous Bacterial Peritonitis In Advanced Cirrhosis

Study design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: Short-term and long-term survival

Secondary outcome:

Prevention of the first episode of spontaneous bacterial peritonitis

Prevention of hepatorenal syndrome

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Age 18-80 years, protein concentration in ascitic fluid < 15 g/L and at least one of

the following: serum creatinine ≥ 1. 2 mg/dl or BUN ≥ 25 mg/dl, serum sodium ≤ 130 mEq/L or severe liver failure as defined by a Child-Pugh score ≥ 9 points and a serum bilirubin ≥ 3 mg/dl.

Exclusion Criteria:

- Previous history of spontaneous bacterial peritonitis or of norfloxacin prophylaxis,

allergy to quinolones, hepatocellular carcinoma, organic renal failure and HIV infection

Hospital Clinic Barcelona, Barcelona, Catalonia 08036, Spain

Starting date: September 2000
Ending date: March 2005
Last updated: August 1, 2006