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Norfloxacin In The Primary Prophylaxis Of Spontaneous Bacterial Peritonitis

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ClinicalTrials.gov Identifier: NCT00359853
Recruitment Status : Completed
First Posted : August 3, 2006
Last Update Posted : August 3, 2006
Information provided by:
Hospital Clinic of Barcelona

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Spontaneous Bacterial Peritonitis Hepatorenal Syndrome Cirrhosis Drug: Oral norfloxacin Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Randomized Double-Blid Placebo Controlled Trial Assessing Norfloxacin In The Primary Prophylaxis Of Spontaneous Bacterial Peritonitis In Advanced Cirrhosis
Study Start Date : September 2000
Estimated Study Completion Date : March 2005

Primary Outcome Measures :
  1. Short-term and long-term survival

Secondary Outcome Measures :
  1. Prevention of the first episode of spontaneous bacterial peritonitis
  2. Prevention of hepatorenal syndrome

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00359853

Hospital Clinic Barcelona
Barcelona, Catalonia, Spain, 08036
Sponsors and Collaborators
Hospital Clinic of Barcelona
Principal Investigator: Miquel Navasa, MD Liver Unit. Hospital Clinic Barcelona

ClinicalTrials.gov Identifier: NCT00359853     History of Changes
Other Study ID Numbers: 00-pbe-mnjf-2
First Posted: August 3, 2006    Key Record Dates
Last Update Posted: August 3, 2006
Last Verified: June 2004

Keywords provided by Hospital Clinic of Barcelona:
Norfloxacin, primary prophylaxis, SBP

Additional relevant MeSH terms:
Liver Cirrhosis
Hepatorenal Syndrome
Pathologic Processes
Liver Diseases
Digestive System Diseases
Intraabdominal Infections
Peritoneal Diseases
Kidney Diseases
Urologic Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors