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Norfloxacin In The Primary Prophylaxis Of Spontaneous Bacterial Peritonitis

This study has been completed.
Sponsor:
Information provided by:
Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT00359853
First received: August 1, 2006
Last updated: NA
Last verified: June 2004
History: No changes posted
  Purpose

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 Intervention Phase
Spontaneous Bacterial Peritonitis
Hepatorenal Syndrome
Cirrhosis
 Drug: Oral norfloxacin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Randomized Double-Blid Placebo Controlled Trial Assessing Norfloxacin In The Primary Prophylaxis Of Spontaneous Bacterial Peritonitis In Advanced Cirrhosis

Resource links provided by NLM:

Drug Information available for: Norfloxacin
U.S. FDA Resources

Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • Short-term and long-term survival

Secondary Outcome Measures:
  • Prevention of the first episode of spontaneous bacterial peritonitis
  • Prevention of hepatorenal syndrome

Estimated Enrollment: 70
Study Start Date: September 2000
Estimated Study Completion Date: March 2005
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00359853

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

No publications provided

ClinicalTrials.gov Identifier: NCT00359853     History of Changes
Other Study ID Numbers: 00-pbe-mnjf-2
Study First Received: August 1, 2006
Last Updated: August 1, 2006
Health Authority: Spain: Spanish Agency of Medicines

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

Additional relevant MeSH terms:
Hepatorenal Syndrome
Liver Cirrhosis
Fibrosis
Peritonitis
Liver Diseases
Digestive System Diseases
Kidney Diseases
Urologic Diseases
Pathologic Processes
 Peritoneal Diseases
Norfloxacin
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013