Norfloxacin In The Primary Prophylaxis Of Spontaneous Bacterial Peritonitis

NCT00359853 | Completed Phase 4

• 1 other identifier: 00-pbe-mnjf-2
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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).

Conditions

Spontaneous Bacterial Peritonitis; Hepatorenal Syndrome; Cirrhosis

Keywords

Norfloxacin, primary prophylaxis, SBP

Outcome Measures

Primary Outcomes (1)

• Short-term and long-term survival

Secondary Outcomes (2)

• Prevention of the first episode of spontaneous bacterial peritonitis

• Prevention of hepatorenal syndrome

Interventions

Oral norfloxacin DRUG

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Previous history of spontaneous bacterial peritonitis or of norfloxacin prophylaxis, allergy to quinolones, hepatocellular carcinoma, organic renal failure and HIV infection

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (1)

Hospital Clinic Barcelona

Barcelona, Catalonia, 08036, Spain

Location

MeSH Terms

Conditions

Hepatorenal Syndrome; Fibrosis

Interventions

Norfloxacin

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Miquel Navasa, MD

  Liver Unit. Hospital Clinic Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 1, 2006
• First Posted: August 3, 2006
• Study Start: September 1, 2000
• Study Completion: March 1, 2005
• Last Updated: August 3, 2006

Record last verified: 2004-06

Locations

ES (1)