Norfloxacin In The Primary Prophylaxis Of Spontaneous Bacterial Peritonitis
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...
Brief Summary
Official Title: “Randomized Double-Blid Placebo Controlled Trial Assessing Norfloxacin In The Primary Prophylaxis Of Spontaneous Bacterial Peritonitis In Advanced Cirrhosis”
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).
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Intervention(s) in this Clinical Trial
- Drug: Oral norfloxacin
Outcome Measures for this Clinical Trial
Primary Measures
- Short-term and long-term survival
Secondary Measures
- Prevention of the first episode of spontaneous bacterial peritonitis
- Prevention of hepatorenal syndrome
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 80 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Hospital Clinic of Barcelona Other
Overall Clinical Trial Officials and Contacts
Miquel Navasa, MD Principal Investigator Liver Unit. Hospital Clinic Barcelona
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00359853
Study ID Number: 00-pbe-mnjf-2
ClinicalTrials.gov Identifier: NCT00359853
Health Authority: Spain: Spanish Agency of Medicines
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00359853
