Randomized Double-Blid Placebo Controlled Trial Assessing Norfloxacin In The Primary Prophylaxis Of Spontaneous Bacterial Peritonitis In Advanced Cirrhosis
Sponsor study identifier
interventional
70
1 country
1
Study Start
September 2000
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
March 2005
Date type not reportedThis date has not been verified as actual or estimated.
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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2005
Date type not reportedThis date has not been verified as actual or estimated.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2000
Date type not reportedThis date has not been verified as actual or estimated.
March 2005
Date type not reportedThis date has not been verified as actual or estimated.
August 1, 2006
Actual (reported)August 3, 2006
Actual (reported)Short-term and long-term survival
Prevention of the first episode of spontaneous bacterial peritonitis
Prevention of hepatorenal syndrome
Hospital Clinic Barcelona
Barcelona, Catalonia, 08036, Spain
Miquel Navasa, MD
Liver Unit. Hospital Clinic Barcelona
First Submitted
August 1, 2006
First Posted
August 3, 2006
Study Start
September 2000
Date type not reportedThis date has not been verified as actual or estimated.
Study Completion
March 2005
Date type not reportedComparative Study of Secondary Prophylaxis for SBP
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This date has not been verified as actual or estimated.
Last Updated
August 3, 2006
Record last verified: 2004-06
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Source: ClinicalTrials.gov.
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