Norfloxacin In The Primary Prophylaxis Of Spontaneous Bacterial Peritonitis
Information source: Hospital Clinic of Barcelona
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Spontaneous Bacterial Peritonitis; Hepatorenal Syndrome; Cirrhosis
Intervention: Oral norfloxacin (Drug)
Phase: Phase 4
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
Prevention of the first episode of spontaneous bacterial peritonitis
Prevention of hepatorenal syndrome
Minimum age: 18 Years.
Maximum age: 80 Years.
- Age 18-80 years, protein concentration in ascitic fluid < 15 g/L and at least one of
the following: serum creatinine â¥ 1. 2 mg/dl or BUN â¥ 25 mg/dl, serum sodium â¤ 130
mEq/L or severe liver failure as defined by a Child-Pugh score â¥ 9 points and a serum
bilirubin â¥ 3 mg/dl.
- Previous history of spontaneous bacterial peritonitis or of norfloxacin prophylaxis,
allergy to quinolones, hepatocellular carcinoma, organic renal failure and HIV
Locations and Contacts
Hospital Clinic Barcelona, Barcelona, Catalonia 08036, Spain
Starting date: September 2000
Ending date: March 2005
Last updated: August 1, 2006