Norfloxacin In The Primary Prophylaxis Of Spontaneous Bacterial Peritonitis

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 Overview

• Status: Completed
• Conditions: Cirrhosis; Hepatorenal Syndrome; Spontaneous Bacterial Peritonitis
• Intervention / Treatment: Drug: Oral norfloxacin

• Study Type: Interventional
• Enrollment: 70
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Catalonia
    • Barcelona, Catalonia, Spain, 08036
      • Hospital Clinic Barcelona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Short-term and long-term survival

Secondary Outcome Measures

Outcome Measure
Prevention of the first episode of spontaneous bacterial peritonitis
Prevention of hepatorenal syndrome

Collaborators and Investigators

• Sponsor: Hospital Clinic of Barcelona
• Investigators: Principal Investigator: Miquel Navasa, MD, Liver Unit. Hospital Clinic Barcelona

Study record dates

Study Major Dates

• Study Start: September 1, 2000
• Study Completion: March 1, 2005

Study Registration Dates

• First Submitted: August 1, 2006
• First Submitted That Met QC Criteria: August 1, 2006
• First Posted (Estimate): August 3, 2006

Study Record Updates

• Last Update Posted (Estimate): August 3, 2006
• Last Update Submitted That Met QC Criteria: August 1, 2006
• Last Verified: June 1, 2004

More Information

Terms related to this study

• Keywords: Norfloxacin, primary prophylaxis, SBP
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Infections; Kidney Diseases; Urologic Diseases; Peritoneal Diseases; Liver Diseases; Intraabdominal Infections; Fibrosis; Liver Cirrhosis; Peritonitis; Hepatorenal Syndrome; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Norfloxacin
• Other Study ID Numbers: 00-pbe-mnjf-2