Norfloxacin In The Primary Prophylaxis Of Spontaneous Bacterial Peritonitis

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

Study Description

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 Design

• Study Type: Interventional (Clinical Trial)
• 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
• Study Completion Date: March 2005

Arms and Interventions

Outcome Measures

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

• ClinicalTrials.gov Identifier: NCT00359853
• Other Study ID Numbers: 00-pbe-mnjf-2
• First Posted: August 3, 2006
• 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:

Peritonitis; Liver Cirrhosis; Hepatorenal Syndrome; Fibrosis; Pathologic Processes; Liver Diseases; Digestive System Diseases; Intraabdominal Infections; Infection; Peritoneal Diseases; Kidney Diseases; Urologic Diseases; Norfloxacin; 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